134 results on '"Cote, Mark P."'
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2. The Fragility Index Is Typically Misinterpreted and of Low Value: Clinical Trials Are Designed to Be Fragile.
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Cote, Mark P., Lubowitz, James H., Rossi, Michael J., and Matzkin, Elizabeth
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The Fragility Index (FI) is defined as the number of patients whose outcome would need to change to reverse a statistically significant finding to a nonsignificant finding. The FI is nothing more than a repackaging of statistical significance based on the P value, perpetuating (1) ignoring of results that are "not" statistically significant; (2) treating results that are statistically significant as certain; and (3) distracting from evaluation of clinical significance. A well-designed trial includes a sample size calculation to determine the minimum number of patients required to observe a difference between study groups (if a difference exists). By including this minimum number, clinical trials are designed to be fragile, yet subsequently criticized as such, leading readers to the incorrect conclusion that the studies are flawed. It's time to move past systematic reviews focused on the FI. [ABSTRACT FROM AUTHOR]
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- 2024
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3. Recommended Requirements and Essential Elements for Proper Reporting of the Use of Artificial Intelligence Machine Learning Tools in Biomedical Research and Scientific Publications.
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Cote, Mark P. and Lubowitz, James H.
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Essential elements required for proper use of artificial intelligence machine learning tools in biomedical research and scientific publications include (1) explanation justifying why a machine learning approach contributes to the purpose of the study; (2) description of the adequacy of the data (input) to produce the desired results (output); (3) details of the algorithmic (i.e., computational) approach including methods for organizing the data (preprocessing); the machine learning computational algorithm(s) assessed; on what data the models were trained; the presence of bias and efforts to mitigate these effects; and the methods for quantifying the variables (features) most influential in determining the results (e.g., Shapley values); (4) description of methods, and reporting of results, quantitating performance in terms of both model accuracy and model calibration (level of confidence in the model's predictions); (5) availability of the programming code (including a link to the code when available—ideally, the code should be available); (6) discussion of model internal validation (results applicable and sensitive to the population investigated and data on which the model was trained) and external validation (were the results investigated as to whether they are generalizable to different populations? If not, consideration of this limitation and discussion of plans for external validation, i.e., next steps). As biomedical research submissions using artificial intelligence technology increase, these requirements could facilitate purposeful use and comprehensive methodological reporting. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Editorial Commentary: The Minimal Clinically Important Difference Is Less Important Than It Sounds: Patients Seek to Achieve Substantial Clinical Benefits and Not Minimally Perceptible Improvements When They Undergo Arthroscopic Surgery.
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Saithna, Adnan and Cote, Mark P.
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The minimal clinically important difference (MCID) is a frequently reported metric for describing within-patient improvement in patient-reported outcome measures (PROMs). It was originally defined by Jaeschke et al. as "the smallest difference in score in the domain of interest which patients perceive as beneficial and which would mandate, in the absence of troublesome side effects and excessive cost, a change in the patient's management." The latter part of this statement is often omitted, and this results in a loss of the originally intended value through lack of sufficient clinical importance to change management. Other pitfalls in the use of the MCID include that they are population- and condition-specific. As such, MCIDs lack external validity and cannot easily be extrapolated from one study to another. Furthermore, broadly different values can be obtained depending on the calculation method used. This makes the MCID an unhelpful metric when seeking to understand the true efficacy of a given intervention. The Food and Drug Administration recommends anchor-based methodologies (which take into account patient perception), over distribution-based methods (which are purely statistical and do not account for clinical meaningfulness to patients). Regardless, it should be noted that even anchor-based methodologies are susceptible to statistical bias, and measures are apt to be influenced by the regression to mean phenomena, where the value of the preintervention scores and their relationship to postintervention scores can bias estimates of the MCID. Finally, when using MCIDs, one must consider that they are a low bar. This means that patients do not undergo treatment to achieve minimally perceptible clinical improvements; instead, they undergo treatment with the hope of achieving substantial clinical benefit or a patient acceptable symptom state, and so these are more appropriate individual-level metrics to consider when evaluating clinically meaningful outcomes of treatment. [ABSTRACT FROM AUTHOR]
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- 2024
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5. Disaggregation of Medical Research Data Reveals Outcome Differences in Demographic Groups and Presents Opportunity to Improve Patient Care.
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Rossi, Michael J., Lubowitz, James H., Cote, Mark P., and Matzkin, Elizabeth
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Disaggregation, in the medical literature, means separation into demographic groups. This results in an opportunity to discover differences in outcomes by group, which could improve future treatments and provide outcome data, by group, that could be included in future systematic reviews. In research, the term disaggregation is most often used in reference to addressing inequities. We support the Sex and Gender Equity Research (SAGER) guidelines and encourage authors to examine how sex and gender are taken into account in their study and ensure adequate representation by sex and gender. (We respect that not all studies can or are designed to capture data by sex and gender, and that gender is "complex" and "fluid.") Disaggregation is encouraged, when possible, for other demographic variables allowing evaluation of all marginalized (as well as nonmarginalized) populations, so that we can better care for patients. [ABSTRACT FROM AUTHOR]
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- 2024
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6. Objective quantification of trochlear dysplasia: Assessment of the difference in morphology between control and chronic patellofemoral instability patients
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Voss, Andreas, Shin, Sangmin Ryan, Murakami, Akira M., Cote, Mark P., Achtnich, Andrea, Herbst, Elmar, Schepsis, Anthony A., and Edgar, Cory
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- 2017
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7. Human Rotator Cuff Tears Reveal an Age-Dependent Increase in Markers of Cellular Senescence and Selective Removal of Senescent Cells With Dasatinib + Quercetin Increases Genetic Expression of COL1A1 In Vitro.
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Hawthorne, Benjamin C., Wellington, Ian J., Sabitsky, Joshua T., Murphy, Kyle V., Karsmarski, Owen P., Thomas, Rohin O., LeVasseur, Matthew R., Mancini, Michael R., Trudeau, Maxwell T., Gulati, Sagar, McCarthy, Mary Beth R., Cote, Mark P., Xu, Ming, and Mazzocca, Augustus D.
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To quantify cellular senescence in supraspinatus tendon and subacromial bursa of humans with rotator cuff tears and to investigate the in vitro efficacy of the senolytic dasatinib + quercetin (D+Q) to eliminate senescent cells and alter tenogenic differentiation. Tissue was harvested from 41 patients (mean age, 62 years) undergoing arthroscopic rotator cuff repairs. In part 1 (n = 35), senescence was quantified using immunohistochemistry and gene expression for senescent cell markers (p16 and p21) and the senescence-associated secretory phenotype (SASP) (interleukin [IL] 6, IL-8, matrix metalloproteinase [MMP] 3, monocyte chemoattractant protein [MCP] 1). Senescence was compared between patients <60 and ≥60 years old. In part 2 (n = 6) , an in vitro model of rotator cuff tears was treated with D+Q or control. D+Q, a chemotherapeutic and plant flavanol, respectively, kill senescent cells. Gene expression analysis assessed the ability of D+Q to kill senescent cells and alter markers of tenogenic differentiation. Part 1 revealed an age-dependent significant increase in the relative expression of p21, IL-6, and IL-8 in tendon and p21, p16, IL-6, IL-8, and MMP-3 in bursa (P <.05). A significant increase was seen in immunohistochemical staining of bursa p21 (P =.028). In part 2, D+Q significantly decreased expression of p21, IL-6, and IL-8 in tendon and p21 and IL-8 in bursa (P <.05). Enzyme-linked immunosorbent assay analysis showed decreased release of the SASP (IL-6, MMP-3, MCP-1; P =.002, P =.024, P <.001, respectively). Tendon (P =.022) and bursa (P =.027) treated with D+Q increased the expression of COL1A1. While there was an age-dependent increase in markers of cellular senescence, this relationship was not consistently seen across all markers and tissues. Dasatinib + quercetin had moderate efficacy in decreasing senescence in these tissues and increasing COL1A1 expression. This study reveals that cellular senescence may be a therapeutic target to alter the biological aging of rotator cuffs and identifies D+Q as a potential therapy. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Editorial Commentary: Regression Modeling and Nomograms in Biomedical Research Are Valuable Decision-Making Tools When Externally Validated and Well Maintained.
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Cote, Mark P. and Grassbaugh, Jason A.
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The mathematical formulas underpinning biostatistical modeling in medical research can be complicated. Nomograms are pictoral tools showing a graphical solution of a formula in which all variables in the formula can be read off the diagram. Nomograms can be used to simplify the calculation of risk of recurrence of injuries or disease. Although nomograms can be valuable, external validation is required (of all models) to ensure accuracy outside of the original population, because variation in patient populations, activities, and risk behaviors outside of the patient data used in the original analysis may deteriorate model performance (external validity). A model also needs to be maintained over time to ensure continued accuracy as populations and activities change. A model that fails to keep up will eventually have its accuracy and clinical utility fade. An externally validated, well-maintained model can be a valuable tool for patient counseling and decision-making. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Editorial Commentary: Ceiling Effects Are a Limitation of Frequently Used Patient-Reported Outcomes Measures Used to Assess Shoulder Function: Appropriate Selection of Shoulder Patient-Reported Outcomes Measures Is Required—Especially in Athletes.
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Saithna, Adnan and Cote, Mark P.
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Ceiling effects (CEs) are a major limitation of frequently used patient-reported outcomes measures (PROMs) in the assessment of shoulder function. It is generally considered that a CE may be present when the best possible score for a given PROM is achieved by at least 15% of the study population. When a CE occurs, it typically indicates that the scoring criteria are relatively easy and therefore may not reliably capture greater levels of patient function. This is a particular problem with the use of activities of daily living–oriented PROMs in the evaluation of athletic patients because they can still score highly, despite limitations in athletic shoulder function. When a CE is present, it can result in failure to determine the true efficacy of a procedure, limited responsiveness to change, and furthermore if a subsequent comparison of 2 groups of patients is undertaken, it may produce similar results despite meaningful differences between them. It is important to recognize that CEs are common and have important consequences but that careful selection of PROMs adapted to the characteristics of the study population and the specific research question can help to mitigate these issues. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Editorial Commentary: The Statistical Fragility Index of Medical Trials Is Low By Design: Critical Evaluation of Confidence Intervals Is Required.
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Cote, Mark P., Asnis, Peter, Hutchinson, Ian D., and Berkson, Eric
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The Fragility Index (FI) provides the number of patients whose outcome would need to have changed for the results of a clinical trial to no longer be statistically significant. Although it's a well-intended and easily interpreted metric, its calculation is based on reversing a significant finding and therefore its interpretation is only relevant in the domain of statistical significance. Its interpretation is only relevant in the domain of statistical significance. A well-designed clinical trial includes an a priori sample size calculation that aims to find the bare minimum of patients needed to obtain statistical significance. Such trials are fragile by design! Examining the robustness of clinical trials requires an estimation of uncertainty, rather than a misconstrued, dichotomous focus on statistical significance. Confidence intervals (CIs) provide a range of values that are compatible with a study's data and help determine the precision of results and the compatibility of the data with different hypotheses. The width of the CI speaks to the precision of the results, and the extent to which the values contained within have potential to be clinically important. Finally, one should not assume that a large FI indicates robust findings. Poorly executed trials are prone to bias, leading to large effects, and therefore, small P values, and a large FI. Let's move our future focus from the FI toward the CI. [ABSTRACT FROM AUTHOR]
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- 2024
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11. Is there value in the routine practice of discarding the incision scalpel from the surgical field to prevent deep wound contamination with Cutibacterium acnes? An update.
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Shroff, Jeffrey B., Hanna, Phillip, Levy, Benjamin J., Jimenez, Andrew E., Grimm, Nathan L., Cote, Mark P., and Mazzocca, Augustus D.
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Cutibacterium acnes is the most common microbe implicated in periprosthetic infection in shoulder arthroplasty. We present an update of a previous pilot study in which we demonstrated the persistence of C acnes on the skin and contamination of the scalpel used for the initial skin incision despite a robust presurgical skin preparation protocol. We collected a consecutive case series of patients undergoing primary or revision anatomic or reverse total shoulder arthroplasty performed by a single fellowship-trained surgeon at a tertiary referral hospital from November 2019 to December 2022. The scalpel blade used for the initial skin incision in each patient was swabbed, with cultures being held for 21 days according to a C acnes –specific protocol. Demographic data, medical comorbidities, surgical information, culture results, and infections were documented. We identified 100 patients (51 men and 49 women) who met the inclusion criteria (mean age, 66.91 years; age range, 44-93 years). Cultures returned positive findings for C acnes in 12 patients (12%), 11 of whom were men (odds ratio, 13.2; 95% confidence interval, 1.73-194.87). No association was found between positive culture findings and age, body mass index, medical comorbidities, or procedure type. No postoperative infections occurred in this patient cohort, and the patients will continue to be monitored for the development of infection. Despite stringent presurgical preparation and scrub protocols, a significant portion of patients undergoing shoulder arthroplasty have C acnes in culturable quantities on their skin at the time of incision. C acnes contamination is much more common in male patients. These findings should be taken into consideration regarding preventive measures such as discarding the initial scalpel and avoiding unnecessary dermal contact during the procedure. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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12. Patient Acceptable Symptomatic State and Substantial Clinical Benefit Matter Most to Patients and Must Be Reported Correctly.
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Brand, Jefferson C., Lubowitz, James H., Cote, Mark P., Matzkin, Elizabeth, and Rossi, Michael J.
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Despite a push for a focus on clinical rather than "statistical" significance and an emphasis on reporting of outcome thresholds such as the patient acceptable symptomatic state (PASS) and substantial clinical benefit (SCB), the PASS and SCB are rarely reported and, when reported, are often reported incorrectly. Yet, patients require satisfaction (PASS) as a result of our treatments, and patients desire to improve substantially (SCB). Determining whether patients are satisfied and/or substantially improved is simple... just ask them. The questions are known as anchor questions. Obviously, different patients have different PASS and SCB thresholds, and reliance on previously published literature for values of these thresholds can result in error—thus, the anchor questions. And, each patient must be assessed individually. Outcome thresholds are not group-level metrics, and they must be reported as the percentage of individuals who achieve the clinically significant outcome. Certain patients, such as athletes, have high baseline function and may demand maximum outcome improvement. In contrast, the minimal clinically important difference is a less-than-ideal measure; patients do not desire "minimal" improvement. Journals must do a better job of publishing patient-reported outcome measures that matter most to patients: satisfaction and substantial benefit. [ABSTRACT FROM AUTHOR]
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- 2024
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13. Editorial Commentary: Utility of Patient-Reported Outcome Threshold Scores to Estimate Patient Satisfaction: 'Let's Ask the Patient!'.
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Cote, Mark P., Jacobs, Cale A., Price, Mark D., and Mazzocca, Augustus D.
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The reporting and analysis of patient-reported outcome measures have come a long way. Since the concept of the minimally clinically important difference was first introduced in 1989, threshold scores have grown to include substantial clinical benefit and patient acceptable symptomatic state (PASS). The initial motivation for developing these thresholds was rooted in separating clinical significance from statistical. These thresholds provide insight into the relationship between scores on patient-reported outcome measures (PROM) and patient-reported improvement and satisfaction. It follows that in order to evaluate PROM scores, the best method for deriving the threshold typically uses an anchor-based methodology, i.e., "ask the patient." Specifically, patients are asked how much change they've experienced and whether they consider their current state to be satisfactory. The responses to these questions are compared with the scores on PROMs to find outcome thresholds that best separate patients who reported no improvement from those who reported minimal improvement, substantial improvement, and satisfaction with their current state of health (PASS). The PASS is of particular importance as it speaks to what arguably matters most to patients—a satisfactory state of health. Finally, viewing the PASS from the perspective of variation from study to study rather than as a uniform classifier is needed to make use of the growing number of papers reporting these thresholds. Examining differences in PASS values across papers can provide insight into how well PROM scores reflect patient satisfaction in different settings. [ABSTRACT FROM AUTHOR]
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- 2024
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14. Editorial Commentary: The Difficulties of Assessing Return to Play and Return to Performance After Ulnar Collateral Ligament Reconstruction.
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Berkson, Eric, O'Donnell, Evan, Cote, Mark, and Mazzocca, Augustus D.
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Ulnar collateral ligament (UCL) tears have moved from a career-ending injury to one in which success is almost expected from reconstruction. In reality, however, success from a UCL reconstruction is not guaranteed. As we have attempted to assess the true success rate of UCL reconstructions, we have also learned the difficulties of this assessment. Rates of return to sport after UCL reconstruction vary by level of play, the primary or revision status of the repair, along with the specific surgical techniques performed, the chronicity of the tear, the rehabilitation protocols associated with the surgery, and more. Return to sport is difficult to assess, as high school, collegiate, and even professional careers can be variable and there are no standard definitions of "returning to play." These variables also affect our assessments of performance after UCL reconstruction. Decisions for UCL reconstructions and appropriate counseling of patients regarding the likelihood of success currently remain an individual process. [ABSTRACT FROM AUTHOR]
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- 2024
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15. Biomechanical evaluation of subscapularis peel repairs augmented with the long head of the biceps tendon for anatomic total shoulder arthroplasty.
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Hawthorne, Benjamin C., Shuman, Matthew E., Wellington, Ian J., Mancini, Michael R., Hewitt, Cory R., Dorsey, Caitlin G., Quintana, Julio O., Talamo, Michael, Obopilwe, Elifho, Cote, Mark P., Mazzocca, Augustus D., and Sethi, Paul M.
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Subscapularis failure is a troublesome complication following anatomic total shoulder arthroplasty (aTSA). Commonly discarded during aTSA, the long head of the biceps tendon (LHBT) may offer an efficient and cheap autograft for the augmentation of the subscapularis repair during aTSA. The purpose of this study was to biomechanically compare a standard subscapularis peel repair to 2 methods of subscapularis peel repair augmented with LHBT. 18 human cadaveric shoulders (61 ± 9 years of age) were used in this study. Shoulders were randomly assigned to biomechanically compare subscapularis peel repair with (1) traditional single-row repair, (2) single row with horizontal LHBT augmentation, or (3) single row with V-shaped LHBT augmentation. Shoulders underwent biomechanical testing on a servohydraulic testing system to compare cyclic displacement, load to failure, and stiffness. There were no significant differences in the cyclic displacement between the 3 techniques in the superior, middle, or inferior portion of the subscapularis repair (P >.05). The horizontal (436.7 ± 113.3 N; P =.011) and V-shape (563.3 ± 101.0 N; P <.001) repair demonstrated significantly greater load to failure compared with traditional repair (344.4 ± 82.4 N). The V-shape repair had significantly greater load to failure compared to the horizontal repair (P <.001). The horizontal (61.6 ± 8.4 N/mm; P <.001) and the V-shape (62.8 ± 6.1; P <.001) repairs demonstrated significantly greater stiffness compared to the traditional repair (47.6 ± 6.2 N). There was no significant difference in the stiffness of the horizontal and V-shape repairs (P =.770). Subscapularis peel repair augmentation with LHBT autograft following aTSA confers greater time zero load to failure and stiffness when compared to a standard subscapularis peel repair. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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16. Guidelines for Proper Reporting of Clinical Significance, Including Minimal Clinically Important Difference, Patient Acceptable Symptomatic State, Substantial Clinical Benefit, and Maximal Outcome Improvement.
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Harris, Joshua D., Brand, Jefferson C., Cote, Mark, Waterman, Brian, and Dhawan, Aman
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Patient-reported outcome measures (PROM) need to be responsive, reliable, and validated for the specific condition or treatment. PROMs also need to exhibit a dose-dependent response across a diverse patient population, unlimited by floor and ceiling effects. Statistically significant differences between compared groups might not always represent clinically important differences. Measures of clinical significance reflect a spectrum of patient satisfaction after an intervention. A noticeable difference to the patient is assessed with minimal clinically important difference (MCID), patient satisfaction by patient acceptable symptomatic state (PASS), and a "considerable" improvement by substantial clinical benefit (SCB). Clinical relevance measured by these clinically significant outcomes (CSO) are limited by ceiling effects. Maximal outcome improvement (MOI) might more accurately account for patients with higher baseline or preoperative PROMs, thereby limiting ceiling effects. The acts of measuring (and reporting) patient-centered endpoints may actually be of greater importance than collecting objective clinician-measured data. As the old surgeon's aphorism goes, "nothing ruins good results like good follow-up." [ABSTRACT FROM AUTHOR]
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- 2023
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17. Biomechanical comparison of lower trapezius and latissimus dorsi transfer for irreparable posterosuperior rotator cuff tears using a dynamic shoulder model.
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Muench, Lukas N., Berthold, Daniel P., Kia, Cameron, Obopilwe, Elifho, Cote, Mark P., Imhoff, Andreas B., Scheiderer, Bastian, Elhassan, Bassem T., Beitzel, Knut, and Mazzocca, Augustus D.
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In the setting of irreparable posterosuperior rotator cuff tears (PSRCTs), lower trapezius transfer (LTT) may be anatomically better positioned for restoring the muscular force couple compared with latissimus dorsi transfer (LDT). The purpose of the study was to evaluate the effect of LTT and LDT on glenohumeral kinematics using a dynamic shoulder model. Ten fresh-frozen cadaveric shoulders (mean age: 56.5 ± 17.2 years) were tested using a dynamic shoulder simulator. The maximum abduction angle (MAA), superior humeral head migration (SHM), and cumulative deltoid forces (CDFs) were compared across 4 conditions: (1) native; (2) irreparable PSRCT; (3) LTT using an Achilles tendon allograft; and (4) LDT. MAA and SHM were measured using 3-dimensional motion tracking. CDF was recorded in real time throughout the dynamic abduction motion by load cells connected to actuators. Compared to the native state, the PSRCT resulted in a significant decrease (Δ–24.1°; P <.001) in MAA, with a subsequent significant increase after LTT (Δ13.1°; P <.001) and LDT (Δ8.9°; P <.001). LTT achieved a significantly greater MAA than LDT (Δ4.2°; P =.004). Regarding SHM, both LTT (Δ–9.4 mm; P <.001) and LDT (Δ–5.0 mm; P =.008) demonstrated a significant decrease compared with the PSRCT state. LTT also achieved significantly less SHM compared with the LDT (Δ–4.4 mm; P =.011). Further, only the LTT resulted in a significant decrease in CDF compared with the PSRCT state (Δ–21.3 N; P =.048), whereas LTT and LDT showed similar CDF (Δ–11.3 N; P =.346). However, no technique was able to restore the MAA, SHM, and CDF of the native shoulder (P <.001, respectively). LTT and LDT both achieved a significant increase in MAA along with significantly less SHM compared with the PSRCT state. Although LTT required significantly less compensatory deltoid forces compared with the PSRCT state, this was not observed for the LDT. Further, the LTT prevented loss of abduction motion and SHM more sufficiently. In the challenging treatment of irreparable PSRCTs, LTT may restore native glenohumeral kinematics more sufficiently, potentially leading to improved postoperative functional outcomes. [ABSTRACT FROM AUTHOR]
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- 2022
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18. Subacromial bursa increases the failure force in a mouse model of supraspinatus detachment and repair.
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Lebaschi, Amir, Kriscenski, Danielle E., Tamburini, Lisa M., McCarthy, Mary Beth, Obopilwe, Elifho, Uyeki, Colin L., Cote, Mark P., Rodeo, Scott A., Kumbar, Sangamesh G., and Mazzocca, Augustus D.
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It has been shown that subacromial bursa (SAB) harbors connective tissue progenitor cells. The purpose of this study was to evaluate the effects of implantation of SAB-derived cells (SBCs) suspended in a fibrin sealant bead and implantation of SAB tissue at rotator cuff repair site on biomechanical properties of the repair in a mouse (C57Bl/6) model of supraspinatus tendon (ST) detachment and repair. Part 1: Murine SAB tissue was harvested and cultured. Viability of SBCs suspended in 10 μL of fibrin sealant beads was confirmed in vitro and in vivo. Eighty mice underwent right ST detachment and repair augmented with either fibrin sealant bead (control group) or fibrin sealant bead with 100,000 SBCs (study group) applied at the repair site. Part 2: 120 mice underwent right ST detachment and repair and were randomized equally into 4 groups: (1) a tissue group, which received a piece of freshly harvested SAB tissue; (2) a cell group, which received SBCs suspended in fibrin sealant bead; (3) a fibrin sealant group, which received plain fibrin sealant bead without cells; and (4) a control group, which received nothing at the ST repair site. An equal number of mice in each group were killed at 2 and 4 weeks. Specimens underwent biomechanical testing to evaluate failure force (part 1 and 2) and histologic analysis of the repair site (part 1 only). Part 1: The mean failure force in the study group was significantly higher than controls at 2 and 4 weeks (3.25 ± 1.03 N vs. 2.43 ± 0.56 N, P =.01, and 4.08 ± 0.99 N vs. 3.02 ± 0.8 N, P =.004, respectively). Mean cell density of the ST at the repair site was significantly lower in the study group at 2 weeks than in controls (18,292.13 ± 1706.41 vs. 29,501.90 ± 3627.49, P =.001). Study group specimens had lower proteoglycan contents than controls, but this difference was not statistically significant. Part 2: There was no difference in failure force between cell and tissue groups at the 2- and 4-week time points (P =.994 and P =.603, respectively). There was no difference in failure force between fibrin sealant bead and control groups at the 2- and 4-week time points (P =.978 and P =.752, respectively). This study shows that the application of SBCs and SAB tissue at the rotator cuff repair site increases the strength of repair in a murine model of rotator cuff detachment and repair. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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19. Outcomes of reverse shoulder arthroplasty following failed superior capsular reconstruction.
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Cusano, Antonio, Kanski, Gregory, Uyeki, Colin, Adams, Kyle, Cote, Mark P., Muench, Lukas N., Connors, John Patrick, Garvin, Patrick, Messina, James C., Berthold, Daniel P., Kissenberth, Michael J., and Mazzocca, Augustus D.
- Abstract
Superior capsular reconstruction (SCR) can be used for massive irreparable rotator cuff tears in the absence of significant degenerative changes; however, those who fail an SCR may require reverse shoulder arthroplasty (RSA). The effect of a previously performed SCR on outcomes following RSA remains unknown. Subjects who underwent RSA from May 2015 to January 2021 at 2 separate institutions were retrospectively identified through prospectively collected databases. Patients who underwent RSA after failed SCR were matched to those who underwent RSA after failed rotator cuff repair (RCR) based on the number of previous ipsilateral shoulder procedures (n = 1, 2, ≥3) and secondarily by age within 5 years. American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) score, Single Assessment Numeric Evaluation (SANE), visual analog scale (VAS) for pain, and Western Ontario Osteoarthritis of the Shoulder index (WOOS) scores were compared between groups. The minimal clinically important difference (MCID), substantial clinical benefit (SCB), and patient acceptable symptomatic state (PASS) thresholds were calculated to determine clinically relevant differences between groups. Forty-five patients were included (32 RSA following RCR, 13 following SCR). There were more smokers (P =.001) and worker's compensation cases (P =.034) in the SCR group. The RCR cohort was older (P =.007) and had a greater incidence of mental health (P >.999) and somatic disorders (P =.698), although these did not reach statistical significance. The mean follow-up for the RCR and SCR groups were 24.2 ± 23.3 and 20.4 ± 14.9 months following RSA, respectively (P =.913). The time from index RCR or SCR to RSA were 94.4 ± 22.2 and 89.2 ± 5.3 months, respectively (P =.003). Pre- and postoperative range of motion were similar between groups, as was the overall change in forward flexion (P =.879), abduction (P =.971), and external rotation (P =.968) following RSA. The RCR group had lower postoperative VAS pain (P =.009), higher SANE (P =.015), higher ASES (P =.008), and higher WOOS (P =.018) scores. The percentage achieving the MCID (P =.676) and SCB (P >.999) were similar; however, 56.7% of the RCR group met the SANE PASS threshold compared with 0.0% in the SCR group (P =.005). There were no differences in postoperative complications (P =.698) or revision rates (P =.308) following RSA between cohorts. When matched for number of previous procedures to the ipsilateral extremity and age, patients who underwent RSA following failed SCR had worse clinical outcome scores than their RSA following failed RCR counterparts. No patient in the SCR group met the SANE PASS threshold, whereas more than half of the RCR group did. [ABSTRACT FROM AUTHOR]
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- 2022
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20. Location and Progression of Chondral Injuries at the Time of Revision Anterior Cruciate Ligament Surgery Varies by Sex.
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Cote, Mark P., Kearney, Garrett J., McKay, Maxwell J., and Tanaka, Miho J.
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To quantify progression of chondral and meniscal injuries between primary and revision anterior cruciate ligament (ACL) surgery. Patients who underwent both index and revision ACL reconstruction between 2000 and 2020 at our institution were identified, and dates of injury and surgery, demographics, and clinical data were obtained from operative reports. Outerbridge grade was recorded in each compartment, along with presence and location of meniscal injury. The frequency of each injury between first and second cases was calculated. Differences in injury and progression were compared over time as well as between patient sex and age. The study included 189 patients (96 female, 93 male). Age at first surgery was 31.7 ± 13.2 years. Mean time to second injury was 3.3 ± 3.0 years. In total, 116 patients had a new or previous chondral injury (odds ratio, 1.6; 95% CI, 1.2-2.1). The medial femoral condyle (31%) and the patella (21%) accounted for the highest proportion of new injury to articular surfaces, whereas new injury to menisci was comparable between the medial (25%) and lateral (23%) meniscus. At the time of revision ACL reconstruction, females had a high prevalence of chondral injuries to the lateral compartment, whereas males had a high prevalence of chondral injury to the medial femoral condyle. The prevalence of new chondral injuries was comparable between sexes, with males having a slightly higher proportion. While time between surgeries, sex, and age had graphical evidence of moderating risk, the effects were small and imprecise. Revision ACL reconstruction carried a 1.6 increase in the odds for new or progressive chondral lesions in our cohort. At the time of revision, females had a relatively higher proportion of lateral-sided chondral injuries, whereas males had a relatively higher proportion of medial femoral condyle injuries. The greatest increase in the prevalence of new and progressive lesions was observed in the medial femoral condyle and trochlea. This progression appeared to be moderated by time between surgeries, patient sex, and age; however, the differences were small and imprecise. Level IV, therapeutic case series. [ABSTRACT FROM AUTHOR]
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- 2024
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21. Increased Glenohumeral Joint Loads Due to a Supraspinatus Tear Can Be Reversed With Rotator Cuff Repair: A Biomechanical Investigation.
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Muench, Lukas N., Berthold, Daniel P., Otto, Alexander, Dyrna, Felix, Bell, Ryan, Obopilwe, Elifho, Cote, Mark P., Imhoff, Andreas B., Mazzocca, Augustus D., and Beitzel, Knut
- Abstract
Purpose: To evaluate the effect of an isolated full-thickness supraspinatus (SSP) tear on glenohumeral kinematics and contact mechanics, as well as to quantify improvement following rotator cuff repair (RCR).Methods: Ten fresh-frozen cadaveric shoulders (mean age: 63.1 ± 4.6 years) were tested using a dynamic shoulder simulator. A pressure-mapping sensor was placed between the humeral head and the glenoid. Each specimen underwent the following three conditions: 1) native, 2) isolated full-thickness SSP tear, and 3) RCR. Maximum abduction angle (MAA) and superior humeral head migration (SHM) were measured using 3D motion tracking software. Cumulative deltoid force (CDF) and glenohumeral contact mechanics, including contact area (GCA) and contact pressure (GCP), were assessed at the resting position, as well as at 15°, 30°, 45°, and 60° of glenohumeral abduction.Results: Compared to native, the SSP tear resulted in a significant decrease in MAA (Δ-8.3°; P < .001) along with a SHM of 6.4 ± 3.8 mm, while significantly increasing CDF (Δ20.5 N; P = .008), GCP (Δ63.1 kPa; P < .001), and peak GCP (Δ278.6 kPa; P < .001), as well as decreasing GCA (Δ-45.8 mm2; P < .001) at each degree of abduction. RCR reduced SHM to 1.2 ± 2.5 mm, while restoring native MAA, CDF (Δ1.8 N), GCA (Δ4.5 mm2), GCP (Δ-4.5 kPa) and peak GCP (Δ19.9 kPa) at each degree of abduction (P > .999, respectively).Conclusion: In a dynamic biomechanical cadaveric model, increased glenohumeral joint loads due to a full-thickness SSP tear can be reversed with RCR. More specifically, RCR restored native glenohumeral contact area and contact pressure, while preventing superior humeral head migration and decreasing compensatory deltoid forces.Clinical Relevance: These time 0 observations indicate that undergoing rotator cuff repair may prevent the development of degenerative changes by significantly reducing glenohumeral joint loads and ensuring sufficiently stable joint kinematics. [ABSTRACT FROM AUTHOR]- Published
- 2022
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22. Subacromial Bursal Tissue and Surrounding Matrix of Patients Undergoing Rotator Cuff Repair Contains Progenitor Cells.
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Levy, Benjamin J., McCarthy, Mary Beth, Lebaschi, Amir, Sanders, Melinda M., Cote, Mark P., and Mazzocca, Augustus D.
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Purpose: To build upon previous literature to identify a complete analysis of cellular contents of subacromial bursal tissue as well as the matrix surrounding the rotator cuff.Methods: Samples of subacromial bursal tissue and surrounding matrix milieu from above the rotator cuff tendon and above the rotator cuff muscle bellies were obtained from 10 patients undergoing arthroscopic rotator cuff repair. Samples were analyzed using fluorescent-activated cell sorting and histologic analysis with staining protocols (Oil Red O, Alcian Blue, and Picro-Sirius Red), for identification of matrix components, including fat, proteoglycans, and collagen.Results: Progenitor cells and fibroblast-type cells were present in significant amounts in subacromial bursal tissue in both tissues obtained from over the tendinous and muscle belly portions. Markers for neural tissue, myeloid cells, and megakaryocytes also were present to a lesser extent. There were prominent amounts of fat and proteoglycans present in the matrix, based on ImageJ analysis of stained histologic slides.Conclusions: The subacromial bursal tissue and surrounding matrix of patients undergoing rotator cuff repair contains progenitor cells in significant concentrations both over the tendon and muscle belly of the rotator cuff.Clinical Relevance: This presence of progenitor cells, in particular, in the subacromial bursal tissue provides a potential basis for future applications of augmentation purposes in rotator cuff healing, and calls into question the practice of routine bursectomy. As the potential role of bursal tissue contents in growth and regeneration in the setting of rotator cuff healing is more well understood, maintaining this tissue may become more relevant. Concentration of these cellular components for use in autologous re-implantation is also an avenue of interest. [ABSTRACT FROM AUTHOR]- Published
- 2022
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23. Effect of reverse total shoulder arthroplasty humeral inclination on glenohumeral range of motion, deltoid force, and glenoid strain: A biomechanical study.
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Joseph, Sheeba M., Dyrna, Felix G.E., Chadayammuri, Vivek, Wiley, Taylor, Obopilwe, Elifho, Scheiderer, Bastian, Beitzel, Knut, Cote, Mark P., Romeo, Anthony A., and Mazzocca, Augustus D.
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ROTATOR cuff injuries ,PROSTHETICS ,RANGE of motion of joints ,REVERSE total shoulder replacement ,ARTIFICIAL joints ,COMPARATIVE studies ,GLENOHUMERAL joint ,DELTOID muscles ,ABDUCTION (Kinesiology) ,BIOMECHANICS ,DEAD ,REHABILITATION - Abstract
Reverse total shoulder arthroplasty (RSA) primarily varies between 2 implant design options: a 135 humeral stem inclination that closely resembles anatomic orientation, versus the Grammont-style 155 humeral stem inclination that further medializes and distalizes the center of rotation (COR). The purpose of this study was to compare deltoid force, glenoid strain, and simulated glenohumeral range of motion (ROM) between RSA 135 and RSA 155 designs, with a series of standardized permutations of glenosphere offset and rotator cuff pathology. Twelve fresh-frozen cadaveric shoulder specimens were studied using a shoulder simulator. Native shoulder motion profiles for reproducible abduction range of motion were established using a customized testing device. Optical 3-dimensional tracking and pressure sensors were used to accurately record glenohumeral range of motion (ROM), deltoid force, and glenoid strain for RSA 135 and RSA 155 designs. For each cohort, all combinations of glenosphere offsets and rotator cuff tendon involvement were evaluated. There was no significant difference in the overall abduction ROM between the 155 and the 135 humeral stem implants (P =.75). Resting abduction angle and maximum abduction angle were significantly greater with a 155 + STD (standard offset) construct than with a 135 + STD construct (P <.001 and P =.01, respectively). Both stem inclinations decreased combined deltoid force requirements as compared the native shoulder with a massive cuff tear. Effective glenoid strain did not vary significantly between 135 + STD and 155 + STD constructs (P =.66). Overall, range of motion between the 135 and the 155 humeral stem inclinations was not significantly different. The cumulative deltoid force was lower in RSA shoulders when compared to native shoulders with massive rotator cuff tears, highlighting the utility of both implant designs. The Grammont-style 155 stem coupled with a 2.5 mm inferior offset glenosphere required less deltoid force to reach maximum abduction than did the more anatomic, lateralized 135 stem coupled with a 4 mm lateral offset glenosphere. Controlled Laboratory Study [Display omitted] [ABSTRACT FROM AUTHOR]
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- 2022
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24. 3-Dimensional Footprint Mapping of the Deltoid and Trapezius: Anatomic Pearls for Acromioclavicular Joint Reconstruction.
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LeVasseur, Matthew R., Mancini, Michael R., Kakazu, Rafael, Cusano, Antonio, Spencer, Mark D., Pina, Matthew J., Cote, Mark P., and Mazzocca, Augustus D.
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Purpose: To perform a quantitative anatomic evaluation of the deltoid and trapezius footprints in relation to the lateral clavicle and acromioclavicular (AC) joint capsule to assist in surgical technique of AC joint reconstructions.Methods: Fourteen fresh-frozen human cadaveric shoulders from 9 donors were analyzed. Meticulous dissection of the deltoid origin and trapezius insertions to the clavicle and AC joint was performed. Footprints were reconstructed using a MicroScribe digitizer. The inferior extension of the deltoid origin beneath the lateral clavicle and the footprints of the deltoid and trapezius onto the acromioclavicular ligamentous complex (ACLC) were quantified. Reproducibility was assessed by redigitizing 5 shoulders in a blinded and random fashion.Results: The anterior deltoid fibers extended on average 4.0 ± 1.6 mm inferiorly with respect to the anteroinferior clavicular ridge and attached to 90.9 ± 7.3% of the anterior ACLC. The trapezius inserted onto the posterior and superior ACLC, covering 15.3 ± 3.4% of the anterior-posterior width of the superior capsule. The deltopectoral interval was 6 cm, or 37% the length of the clavicle from the distal end of the clavicle.Conclusions: The deltoid has superior, anterior, and not as well described, inferior attachments to the lateral clavicle. Furthermore, the deltoid and trapezius muscles have intimate attachments to the AC joint capsule, particularly the trapezius to the posterior and posterosuperior capsule. Lastly, the deltoid origin attaches to the lateral 6 cm of the clavicle.Clinical Relevance: Subperiosteal elevation of the deltoid off the lateral clavicle starting superiorly, anteriorly, and lastly inferiorly will reduce deltoid muscle injury and improve visibility of the coracoid process during reconstruction. Furthermore, knowledge of the attachments of the deltoid and trapezius to the ACLC may help limit iatrogenic injury to these dynamic stabilizers. [ABSTRACT FROM AUTHOR]- Published
- 2022
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25. Biconcave glenoids show 3 differently oriented posterior erosion patterns.
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Otto, Alexander, Scheiderer, Bastian, Murphy, Matthew, Savino, Alexander, Mehl, Julian, Kia, Cameron, Obopilwe, Elifho, DiVenere, Jessica, Cote, Mark P., Denard, Patrick J., Romeo, Anthony A., and Mazzocca, Augustus D.
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Posterior glenoid wear remains a challenge in anatomic and reverse total shoulder arthroplasty (rTSA) because of an asymmetric erosion with altered retroversion. The purpose of this study was to assess glenoid morphology and evaluate the influence of acromial orientation in posterior glenoid erosion patterns by using 3-dimensional (3D) models. Computed tomographic (CT) shoulder scans from 3 study centers of patients awaiting rTSA between 2017 and 2018 were converted into 3D models and analyzed by 2 observers. Morphology, orientation and greatest depth of erosion, inclination, current retroversion and premorbid retroversion, surface areas of the glenoid, and external acromial orientation and posterior acromial slope were assessed. Measurements were compared between wear patterns, glenoid erosion entities, and genders. In the complete cohort of 68 patients (63.8 ± 10.0 years; 19 female, 49 male), a mean of 85.9° (±22.2°) was observed for the glenoid erosion orientation. Additionally, a further distinct classification of the glenoid erosion as posterior-central (PC, n = 39), posterior-inferior (PI, n = 12), and posterior-superior (PS, n = 17) wear patterns was possible. These wear patterns significantly (P <.001) distinguished by erosion orientation (PC = 86.9° ± 12.0°, PI = 116.3° ± 10.3°, PS = 62.3° ± 18.9°). The greatest depth of erosion found was 7.3 ± 2.7 mm in PC wear patterns (PC vs. PI: P =.03; PC vs. PS: n.s.; PI vs. PS: n.s.). Overall, the observed erosion divided the glenoid surface into a paleoglenoid proportion of 48% (±11%) and a neoglenoid proportion of 52% (±12%). For the complete cohort, glenoid inclination was 85.4° (±6.6°), premorbid glenoid retroversion was 80.7° (±8.1°), and current glenoid retroversion was 73.4° (±7.4°), with an estimated increase of 6.9° (±6.0°). The mean external acromial orientation was 118.2° (±8.9°), and the mean posterior acromial slope was 107.2° (±9.6°). There were no further significant differences if parameters were compared by wear patterns, entities, and gender. Three significantly differently oriented wear patterns (posterior-superior, posterior-central, and posterior-inferior) were distinguished in shoulders demonstrating posterior wear on axillary imaging. No significant differences between the observed erosion patterns or any relevant correlations were found regarding the orientation of the acromion. [ABSTRACT FROM AUTHOR]
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- 2021
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26. Nearly One-Third of Published Systematic Reviews and Meta-analyses Yield Inconclusive Conclusions: A Systematic Review.
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Harris, Joshua D., Cote, Mark P., Dhawan, Aman, Hohmann, Erik, and Brand, Jefferson C.
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Purpose: To perform a systematic review that determines the percentage of published orthopedic surgery and sports medicine systematic reviews and meta-analyses that have a conclusive conclusion.Methods: A systematic review was performed using PRISMA guidelines. Six high-quality orthopedics journals were chosen for analysis over a 10-year eligibility period. Systematic reviews and meta-analyses published in these journals were included in the investigation. Narrative, scoping, and umbrella reviews were excluded. A systematic review or meta-analysis was defined as having an inconclusive conclusion if the conclusion in the manuscript body or abstract was stated directly as inconclusive, indeterminate, unknown, or having a lack of evidence (or no evidence). A conclusive conclusion stated a direct answer to the study's primary and/or accessory outcomes. Due to the categorical nature of the data, comparisons were made using χ2 test and logistic regression.Results: There were 1,108 systematic reviews/meta-analyses analyzed (30.9 ± 70.3 studies analyzed per review). More reviews (69.9%) were published with conclusive conclusions rather than without (30.1%). More reviews were surgical (73%) rather than nonsurgical. The United States and North America published the most reviews by country and continent, respectively. There were statistically significant differences between countries (highest proportion with China) and continents (highest proportion with Asia) based on the number of conclusive conclusions in published reviews, respectively. There were no significant differences in the proportion of conclusive conclusion reviews between the 6 analyzed journals. Australia published the largest proportion on nonsurgical reviews. The British Journal of Sports Medicine published a significantly higher proportion of nonsurgical reviews than the other 5 journals. There was no temporal relationship with the proportion of conclusive conclusion reviews.Conclusions: This systematic review observed that only 70% of orthopedic systematic reviews and meta-analyses published in 6 high-quality orthopedic journals over a 10-year eligibility period had conclusive conclusions.Level Of Evidence: Level IV, systematic review and/or meta-analysis of studies with Levels I to IV. [ABSTRACT FROM AUTHOR]- Published
- 2021
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27. A new approach to superior capsular reconstruction with hamstring allograft for irreparable posterosuperior rotator cuff tears: a dynamic biomechanical evaluation.
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Berthold, Daniel P., Bell, Ryan, Muench, Lukas N., Jimenez, Andrew E., Cote, Mark P., Obopilwe, Elifho, and Edgar, Cory M.
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Superior capsular reconstruction (SCR) treatment of massive, symptomatic, irreparable rotator cuff tears (RCTs) has become a more recently used procedure. However, there is a lack of consensus surrounding optimal graft choice for the SCR technique, and current dermal grafts have increased cost and are technically challenging because of a need for multiple implants. The purpose of this study was to biomechanically investigate a biological lower-cost alternative as a support for the superior capsule reconstruction concept: an isolated semitendinosus tendon (STT) allograft and a combination graft with the long head of the biceps tendon (LHBT) in an established massive posterosuperior RCT cadaver model. Ten fresh-frozen cadaveric shoulders (53.3 ± 12.4 years: range: 26-65) were tested on an established dynamic shoulder simulator using dynamic muscle loading. Cumulative deltoid forces, maximum abduction angle, and superior humeral head translation were compared across 4 testing conditions: (1) intact state, (2) massively retracted (Patte III), irreparable posterosuperior RCT, (3) SCR repair using an STT allograft, and (4) SCR repair using a combined STT-LHBT repair. Intact shoulders required a mean deltoid force of 154.2 ± 20.41 N to achieve maximum glenohumeral abduction (55.3° ± 2.3°). Compared with native shoulders, the maximum abduction angle decreased following a massively retracted posterosuperior RCT by 52% (28.3° ± 8.4°; P <.001), whereas the cumulative deltoid forces increased by 48% (205.3 ± 40.9 N; P =.001). The STT repair and the STT-LHBT repair improved shoulder function compared with the tear state, with a mean maximum abduction angle of 30.6° ± 9.0° and 31.8° ± 7.7° and a mean deltoid force of 205.3 ± 40.9 N and 201.0 ± 34.0 N, respectively, but this was not statistically significant (P >.05). The STT-LHBT repair significantly improved the range of motion with respect to the tear state (P =.04). In a dynamic shoulder simulator model, both the STT and the STT-LHBT repair techniques improved glenohumeral joint kinematics in an amount similar to previously reported "traditional" SCR techniques for treatment of an irreparable posterosuperior RCT. [ABSTRACT FROM AUTHOR]
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- 2021
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28. The interaction between human rotator cuff tendon and subacromial bursal tissue in co-culture.
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Tamburini, Lisa M., Levy, Benjamin J., McCarthy, Mary Beth, Kriscenski, Danielle E., Cote, Mark P., Applonie, Ryan, Lebaschi, Amir, Sethi, Paul M., Blaine, Theodore A., and Mazzocca, Augustus D.
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The role of subacromial bursa in rotator cuff pathology is unclear. Along with recognized inflammatory potential, current data demonstrate the presence of mesenchymal stem cells and potential regenerative properties of the bursa. The purpose of this study was to (1) approximate an in vitro co-culture model that represents interaction between torn rotator cuff tendon and subacromial bursa, (2) quantify the cellular activity of tendon and bursa and their interactions, (3) use this model to induce a state of inflammation present with rotator cuff pathology. In part 1, tendon and bursa samples were obtained from 6 patients undergoing rotator cuff repair. Tendon and bursa were cultured alone and together in co-culture wells for 21 days. Markers specific for tenocyte gene expression (tenascin C, decorin, etc) were measured in both tendon and bursa alone and compared to co-culture models. In part 2 of the study, an inflammatory state was induced with interleukin-1β treatment, and markers of inflammation were measured via protein assay at 0 and 21 days in samples from 7 additional patients. There was an increase in tendon and bursa markers in nearly all groups as evidenced by increased gene expression of known tendon and bursa markers. There was a significant increase in gene expression when torn tendon was co-cultured with bursa compared with culturing alone. Additionally, a state of inflammation was induced as evidenced by increased markers of inflammation, inflammatory protein concentration, and inflammatory cells and disruption of histologic morphology. There is a clear interaction between rotator cuff tendon and the milieu produced by the subacromial bursa in this in vitro co-culture system that is significantly different when compared to an isolated culture of tendon and bursa. This system was successfully used to induce a state of inflammation that may represent in vivo inflammation. This in vitro model of rotator cuff pathology can aid investigators in testing effects of agents proposed to improve rotator cuff healing. This can lead to further knowledge regarding effective treatment options. [ABSTRACT FROM AUTHOR]
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- 2021
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29. Understanding Network Meta-analysis (NMA) Conclusions Requires Scrutiny of Methods and Results: Introduction to NMA and the Geometry of Evidence.
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Cote, Mark P., Lubowitz, James H., Brand, Jefferson C., and Rossi, Michael J.
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Synthesis of medical literature to determine the best treatment for a given problem is challenging, particularly when multiple options exist. Network meta-analysis (NMA) allows the comparison of different treatment approaches in a single, systematic review including treatments that have never been compared head-to-head. A key to understanding NMA is to focus on the network geometry showing the number of included studies and their relationships: different treatment options are illustrated as nodes. Lines between nodes represent direct comparisons. For nodes not directly compared, indirect effects may be determined by use of the property of transitivity. Limitations of NMA include heterogeneity, where variability among included studies biases pairwise comparisons, and consistency, if direct and indirect comparisons between treatments do not agree. In the end, NMA allows numeric ranking of the estimated effects of each treatment from most to least effective. A disadvantage of NMA ranking methods is that readers may focus overly on what treatment ranks best and focus insufficiently on the methods and results that determine the rankings. The reliability of the rankings requires consideration of the geometry and strength of the network, including evaluation of heterogeneity, consistency, and transitivity. The conclusion of an NMA requires scrutiny of the methods and results. [ABSTRACT FROM AUTHOR]
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- 2021
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30. Nucleated Cell Count Has Negligible Predictive Value for the Number of Colony-Forming Units for Connective Tissue Progenitor Cells (Stem Cells) in Bone Marrow Aspirate Harvested From the Proximal Humerus During Arthroscopic Rotator Cuff Repair.
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Muench, Lukas N., Berthold, Daniel P., Kia, Cameron, Otto, Alexander, Cote, Mark P., McCarthy, Mary Beth, Mazzocca, Augustus D., and Mehl, Julian
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Purpose: To evaluate whether nucleated cell count (NCC) could serve as an approximation for the number of colony-forming units (CFUs) in concentrated bone marrow aspirate (cBMA) obtained from the proximal humerus.Methods: Bone marrow aspirate (BMA) was harvested from the proximal humerus in 96 patients (mean age 56.2 ± 7.0 years) during arthroscopic rotator cuff repair. Following concentration of the aspirate, nucleated cells of each sample were counted. The total number of CFUs was evaluated under the microscope at their first appearance, usually after 5 to 10 days in culture. Fluorescence-activated cell sorting analysis and assays for osteogenic, adipogenic, and chondrogenic differentiation were performed. Linear regression was assessed to predict the number of CFUs by using NCC. Age, sex, and body mass index (BMI) were evaluated as independent variables.Results: The average volume of the obtained BMA was 86.7 ± 35.2 mL. The cBMA contained a mean of 26.3 ± 6.8 × 106 nucleated cells per mL, which yielded a mean of 1421.7 ± 802.7 CFUs in cell culture. There were no significant differences in NCC or number of CFUs when sex, volume of BMA, age, or BMI was examined independently (P >.05, respectively). Linear regression found that NCC was of limited predictive value for the total number of CFUs being yielded after cell culture (r2 = 0.28 with a root mean square error of 679.4).Conclusion: NCC was of negligible predictive value for the total number of CFUs for connective tissue progenitor cells in BMA harvested from the proximal humerus during arthroscopic rotator cuff repair.Clinical Relevance: NCC is often used to assess the quality of cBMA samples for biological augmentation during surgery. The limited predictive value of this measurement tool is of clinical importance, because effectiveness of BMA applications has been suggested to depend on the concentration of progenitor cells within the sample. [ABSTRACT FROM AUTHOR]- Published
- 2021
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31. Artificial Intelligence, Machine Learning, and Medicine: A Little Background Goes a Long Way Toward Understanding.
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Cote, Mark P., Lubowitz, James H., Brand, Jefferson C., and Rossi, Michael J.
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Artificial intelligence (AI) and machine learning refer to computers built and programed by humans to perform tasks according to our design. This is vital to keep in mind as we try to understand the application of AI to medicine. AI is a tool with strengths and limitations. The primary strength of AI is that it allows us to assimilate and process unlimited quantities of health care data. The limits of AI include the inability of machines to adapt in a human sense, the reality that machines lack human insight (i.e., clinical judgment or common sense), and the limitation that machine-learning algorithms are subject to the data on which they are trained. Thus, we must adapt to AI and machine learning. Next, because machine learning is a type of AI in which computers are programmed to improve the algorithms under which they function over time, we require insight to achieve an element of explainability about the key data underlining a particular machine-learning prediction. Finally, machine-learning algorithms require validation before they can be applied to data sets different from the data on which they were trained. As computers have become faster and more powerful, and as the availability of digital data has become immense, we can program our machines to analyze data and recognize patterns that, in sum, are a primary basis of medical diagnosis and treatment. [ABSTRACT FROM AUTHOR]
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- 2021
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32. Postoperative Radiographic Outcomes Following Primary Open Coracoid Transfer (Bristow-Latarjet) Vary in Definition, Classification, and Imaging Modality: A Systematic Review.
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DeClercq, Madeleine G., Martin, Maitland D., Whalen, Ryan J., Cote, Mark P., Midtgaard, Kaare S., Peebles, Liam A., Di Giacomo, Giovanni, and Provencher, Matthew T.
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To analyze radiographic outcomes by conventional radiography, computed tomography (CT), or both and complication rates of open coracoid transfer at a minimum of 12-months follow-up. A literature search was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, using PubMed, Medline (Ovid), and EMBASE library databases. Inclusion criteria were clinical studies reporting on open Latarjet as the primary surgical procedure(revision coracoid transfer after failed prior stabilization excluded) with postoperative radiographic outcomes at a minimum mean 1-year follow-up. Patient demographics, type of postoperative imaging modality, and radiographic outcomes and complications including graft union, osteoarthritis, and osteolysis were systematically reviewed. Data were summarized as ranges of reported values for each outcome metric. Each radiographic outcome was graphically represented in a Forest plot with point estimates of the incidence of radiographic outcomes with corresponding 95% confidence intervals and I
2 . Thirty-three studies met inclusion criteria, with a total of 1,456 shoulders. The most common postoperative imaging modality was plain radiography only (n = 848 [58.2%]), both CT and radiography (n = 287 [19.7%]), and CT only (n = 321 [22.1%]). Overall, the reported graft union rate ranged from 75% to 100%, of which 79.8% (n = 395) were detected on plain radiography. The most common reported postoperative radiographic complications after the open coracoid transfer were osteoarthritis (range, 0%-100%, pooled mean 28%), graft osteolysis (range, 0%-100%, pooled mean 30%), nonunion (range, 0%-32%, pooled mean 5.1%), malpositioned graft (range, 0%-75%, pooled mean 14.75%), hardware issues (range, 0%-9.1%, pooled mean 5%), and bone block fracture (range, 0%-8%, pooled mean 2.1%). Graft healing was achieved in a majority of cases (range, 75%-100%). Postoperative radiographic outcomes after open coracoid transfer vary greatly in definition, classification, and imaging modality of choice. Greater consistency in postoperative radiographic outcomes is essential to evaluate graft healing, osteolysis, and nonunion. Level IV, systematic review of Level III-IV studies. [ABSTRACT FROM AUTHOR]- Published
- 2024
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33. Invention Versus Gold Standard: A Hands-On Research Pearl on Study Design and Statistical Concerns.
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Kartus, Jüri, Cote, Mark P., and Cote, Mark
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This article points out what is important to consider when planning to perform and analyze a commonly seen study involving a comparison of an innovation with something established. A hands-on guide on how to perform this type of research trial and how to choose proper statistical methods is given. [ABSTRACT FROM AUTHOR]
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- 2018
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34. Misinterpretation of P Values and Statistical Power Creates a False Sense of Certainty: Statistical Significance, Lack of Significance, and the Uncertainty Challenge.
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Cote, Mark P., Lubowitz, James H., Brand, Jefferson C., and Rossi, Michael J.
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Despite great advances in our understanding of statistics, a focus on statistical significance and P values, or lack of significance and power, persists. Unfortunately, this dichotomizes research findings comparing differences between groups or treatments as either significant or not significant. This creates a false and incorrect sense of certainty. Statistics provide us a measure of the degree of uncertainty or random error in our data. To improve the way in which we communicate and understand our results, we must include in reporting a probability, or estimate, of our degree of certainty (or uncertainty). This will allow us to better determine the risks and benefits of a treatment or intervention. Approaches that allow us to estimate, account for, and report our degree of uncertainty include use of confidence intervals, P-value functions, and Bayesian inference (which incorporates prior knowledge in our analysis of new research data). Surprise values (S values, which convert P values to the number of successive identical results of flips of a fair coin) express outcomes in an intuitive manner less susceptible to dichotomizing results as significant or not significant. In the future, researchers may report P values (if they wish) but could go further and provide a confidence interval, draw a P-value function graph, or run a Bayesian analysis. Authors could calculate and report an S value. It is insufficient to mindlessly report results as significant versus not significant without providing a quantitative estimate of the uncertainty of the data. [ABSTRACT FROM AUTHOR]
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- 2021
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35. Editorial Commentary: Preoperative Patient-Reported Outcomes Measurement Information System Scores Vary Over Time.
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Garvin, Patrick and Cote, Mark P.
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Patient-Reported Outcomes Measurement Information System (PROMIS) scores have considerable potential to both streamline the collection of outcome data and provide a common set of metrics to compare and benchmark patient-reported outcomes after orthopaedic procedures. An analysis of PROMIS scores collected at the preoperative clinical visit and the day of surgery found considerable changes in upper- and lower-extremity physical function, pain interference, and depression. These findings suggest that health status may vary between the day of operative consent and the day of surgery. Given the importance of patient-reported outcomes in clinical research, quality assurance, and value-based health care, the potential for large changes in scores leading up to the procedure warrants attention toward the timing of PROMIS administration to ensure that the health status of the patient-and its variation-is accurately captured. [ABSTRACT FROM AUTHOR]
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- 2022
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36. Author Reply to "Placebo Trials in Orthopaedic Surgery" and "Review of Randomized Placebo-Controlled Trials".
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Sochacki, Kyle R., Dong, David, Harris, Joshua D., Mather, Richard C., Nwachukwu, Benedict U., Nho, Shane J., and Cote, Mark P.
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- 2020
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37. Subacromial Bursa-Derived Cells Demonstrate High Proliferation Potential Regardless of Patient Demographics and Rotator Cuff Tear Characteristics.
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Muench, Lukas N., Baldino, Joshua B., Berthold, Daniel P., Kia, Cameron, Lebaschi, Amir, Cote, Mark P., McCarthy, Mary Beth, and Mazzocca, Augustus D.
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Purpose: To investigate the influence of patient demographics and rotator cuff tear characteristics on the cellular proliferation potential of subacromial bursa-derived cells (SBDCs).Methods: Patients undergoing arthroscopic rotator cuff repair between December 2017 and February 2019 were considered for enrollment in the study. Basic demographic information as well as medical and surgical history were obtained for each patient. Subacromial bursa was harvested from over the rotator cuff tendon. Cellular proliferation was evaluated after 3 weeks of incubation by counting nucleated SBDCs. Fluorescence-activated cell sorting (FACS) analysis was performed to confirm the presence of mesenchymal stem cell (MSC) specific surface markers. Using preoperative radiographs and magnetic resonance imaging (MRI), acromiohumeral distance (AHD), severity of cuff tear arthropathy, and rotator cuff tear characteristics were evaluated.Results: Seventy-three patients (mean age: 57.2 ± 8.5 years) were included in the study. There was no significant difference in cellular proliferation of SBDCs when evaluating the influence of age, sex, body mass index (BMI), smoking status, and presence of systemic comorbidities (p > .05, respectively). Similarly, there was no significant difference in cellular proliferation of SBDCs when looking at rotator cuff tear characteristics (size, tendon retraction, fatty infiltration, muscle atrophy), AHD, or severity of cuff tear arthropathy (p > .05). FACS analysis confirmed nucleated SBDCs to have a high positive rate of MSC specific surface markers.Conclusion: Subacromial bursa consistently demonstrated a high cellular proliferation potential regardless of patient demographics, rotator cuff tear characteristics, and severity of glenohumeral joint degeneration.Clinical Relevance: These findings may alleviate concerns that subacromial bursa might lose cellular proliferation potential when being used for biologic augmentation in massive and degenerated rotator cuff tears, thus assisting in predicting tendon healing and facilitating surgical decision-making. [ABSTRACT FROM AUTHOR]- Published
- 2020
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38. Glenoid version is associated with different labrum tear patterns in shoulder instability.
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Mehl, Julian, Hedgecock, Jon, Otto, Alexander, Flaherty, Eilish, Jacoby, Brigitte, DiVenere, Jessica, Cote, Mark, and Mazzocca, Augustus D.
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Previous studies have evaluated glenoid version as a risk factor for anterior and posterior shoulder instability. However, the association of glenoid version with combined anterior-inferior-posterior (>180°) labrum injuries is unknown. The purpose of the present study was to investigate various parameters of glenoid morphology, including version, in >180° labral tears and to compare these values with isolated anterior and isolated posterior tears. Magnetic resonance imaging studies from a consecutive series of shoulder instability patients were reviewed by 3 independent observers to measure the parameters of glenoid morphology including superior-inferior and anterior-posterior diameter, diameter ratio, glenoid version using the glenoid vault method, and percentage of glenoid bone loss using the best-fit circle method. These parameters were compared between patients with anterior (group 1), posterior (group 2), and >180° labral tears (group 3). Interobserver reliability coefficients were calculated for all measurements assessed. There were statistically significant differences for all group comparisons regarding the glenoid version, with group 2 having the most retroversion (19.9° ± 4.71°) followed by group 3 (14.21° ± 4.59°) and group 1 (11.24° ± 5.3°). Group 3 showed the lowest amount of glenoid bone loss; however, the group differences did not reach statistical significance. There was also no statistically significant group difference for the other measured parameters. Interobserver reliability was in the good to excellent range for all measurements. Combined anterior-inferior-posterior labral tears are associated with an increased amount of glenoid retroversion compared with isolated anterior labral tears. Isolated posterior labral tears have the largest amount of glenoid retroversion of all tear patterns. [ABSTRACT FROM AUTHOR]
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- 2020
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39. Intraoperative and In Vitro Classification of Subacromial Bursal Tissue.
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Baldino, Joshua B., Muench, Lukas N., Kia, Cameron, Johnson, Jeremiah, Morikawa, Daichi, Tamburini, Lisa, Landry, Arthur, Gordon-Hackshaw, Lemuel, Bellas, Nicholas, McCarthy, Mary Beth, Cote, Mark P., and Mazzocca, Augustus D.
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Purpose: To classify subacromial bursal tissue using intraoperative and in vitro characteristics from specimens harvested during arthroscopic shoulder surgery.Methods: Subacromial bursa was harvested over the rotator cuff from 48 patients (57 ± 10 years) undergoing arthroscopic shoulder surgery. Specimens were characterized intraoperatively by location (over rotator cuff tendon or muscle), tissue quality (percent of either fatty or fibrous infiltration), and vascularity before complete debridement. Nucleated cell counts were determined after 3 weeks incubation and histological sections were reviewed for degree of fatty infiltration and vascularity. Mesenchymal stem cell surface markers were counted via flow cytometry (n = 3) and cellular migration was observed using a fluoroscopic assay (n = 3).Results: Intraoperatively, muscle bursa was found most often to have >50% fatty infiltration (n = 39), whereas tendon bursa showed majority fibrous tissue (n = 32). Cellular proliferation did not significantly differ according to intraoperative tissue quality. Intraoperative vascularity was associated with greater proliferation for highly vascular samples (P = 0.023). Tendon bursa demonstrated significantly greater proliferation potential than muscle bursa (P = 0.00015). Histologic assessment of fatty infiltration was moderately correlated with gross tissue fattiness (ρ = -0.626, P = 7.14 × 10-11). Flow cytometry showed that 90% to 100% of bursal cells were positive for MSC surface markers. Peak cellular migration rates occurred between 18 and 30 hours' incubation.Conclusions: Intraoperative and in vitro subacromial bursa characteristics were not found to reliably correlate with the degree of cellular proliferation. However, the anatomic location of subacromial bursa was consistently predictive of increased proliferation potential. Bursa-derived nucleated cells were confirmed to include mesenchymal stem cells with migratory potential.Clinical Relevance: The anatomic distinction between muscle and tendon bursa provides a simple classification for predicting cellular activity. [ABSTRACT FROM AUTHOR]- Published
- 2020
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40. Inlay hemiarthroplasty of the humeral head for nontraumatic osteonecrosis.
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Allen, Donald A., Merrill, Christian, Cote, Mark P., and Mazzocca, Augustus D.
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ARTHROPLASTY ,OSTEONECROSIS ,HUMERUS ,RANGE of motion of joints ,QUESTIONNAIRES ,RADIOGRAPHY ,ROTATIONAL motion ,SCAPULA ,SHOULDER surgery ,TREATMENT effectiveness ,RETROSPECTIVE studies ,FUNCTIONAL assessment ,DESCRIPTIVE statistics ,HEMIARTHROPLASTY - Abstract
Osteonecrosis of the humeral head often occurs in younger individuals and presents a difficult clinical situation. The purpose of this study was to evaluate the patient reported outcomes in patients undergoing inlay hemiarthroplasty for nontraumatic osteonecrosis of the humeral head. We hypothesized that patients would achieve a meaningful clinical improvement. A retrospective review of prospectively collected data on 9 patients undergoing inlay hemiarthroplasty for humeral head osteonecrosis was conducted. The American Shoulder and Elbow Surgeons Shoulder score (ASES), Simple Shoulder Test (SST), visual analog scale for pain (VAS), and range of motion measurements were collected preoperatively and at final follow-up. Radiographs were evaluated for any evidence of component loosening or glenoid wear. The primary outcome was achievement of substantial clinical benefit (SCB) for ASES. Postoperatively at a mean of 7.2 years the ASES improved from 35 to 73 (p = 0.011), the SST improved from 2 to 6 (p = 0.038), and the VAS for pain decreased from 7 to 3 (p = 0.009). Forward elevation increased from 96° to 138° (p = 0.012) and external rotation increased from 13° to 63° (p = 0.007). SCB for ASES was seen in 7 out of the 9 patients (78%). Asymptomatic mild or moderate glenoid wear was seen in 4/9 (44%) of patients. One patient (11%) developed symptomatic glenoid wear necessitating conversion to total shoulder arthroplasty. Inlay hemiarthroplasty offers a viable solution to osteonecrosis of the humeral head. Level of Evidence: Level IV; Treatment Study [ABSTRACT FROM AUTHOR]
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- 2020
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41. Clinical Outcomes Following Biologically Enhanced Patch Augmentation Repair as a Salvage Procedure for Revision Massive Rotator Cuff Tears.
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Muench, Lukas N., Kia, Cameron, Jerliu, Aulon, Williams, Ariel A., Berthold, Daniel P., Cote, Mark P., McCarthy, Mary Beth, Arciero, Robert A., and Mazzocca, Augustus D.
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Purpose: To evaluate the clinical outcomes of patients who underwent biologically enhanced patch augmentation repair for the treatment of revision massive rotator cuff tears.Methods: Twenty-two patients who underwent arthroscopic and mini-open rotator cuff repair using a patch augmented with platelet-rich plasma and concentrated bone marrow aspirate (cBMA) for revision massive (≥2 tendons) rotator cuff tears from 2009 to 2014, with a minimum 1-year follow-up, were included in the study. In this procedure the medial side of the graft is secured to the rotator cuff tendon remaining medially. American Shoulder and Elbow Surgeons (ASES), Simple Shoulder Test, and postoperative Single Assessment Numerical Evaluation scores were evaluated. To determine the clinical relevance of ASES scores, the minimal clinically important difference, substantial clinical benefit (SCB), and the patient-acceptable symptomatic state (PASS) thresholds were used. Clinical success or failure was defined based on whether the patient reached the SCB threshold. In the laboratory, cellular counting along with the concentration of connective tissue progenitor cells were performed on patch samples from the day of surgery. Scaffolds were processed histologically at days 0, 7,14, and 21 of culture.Results: Patients had significant improvement in the Simple Shoulder Test (2.6 ± 3.0pre vs 5.2 ± 4.2post, P = .01), whereas improvement in pain scores was found to be nonsignificant (5.6 ± 2.5pre vs 4.2 ± 3.4post,P = .11) at final follow-up. Mean ASES improved by Δ14.6 ± 33.4 points; however, this did not reach statistical significance (40.2 ± 21.6pre vs 53.9 ± 31.4post,P = .10). With regards to ASES score, 45% of patients achieved the minimal clinically important difference, 41% the SCB, and 32% reached or exceeded the PASS criteria. At 21 days, there was a significantly greater cell count in scaffolds from patients who had clinical success than those who were failures (P = .02).Conclusions: Only 41% of patients undergoing biologically enhanced patch augmentation repair reached substantial clinical benefit, whereas 32% reached or exceeded the PASS criteria.Level Of Evidence: Case Series: Level IV. [ABSTRACT FROM AUTHOR]- Published
- 2020
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42. Quantifying Surgeon Work in Total Hip and Knee Arthroplasty: Where Do We Stand Today?
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Halawi, Mohamad J., Mirza, Mohsin, Osman, Nebiyu, Cote, Mark P., Kerr, Joshua M., and Huddleston, James I.
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Background: Physician work is a critical component in determining reimbursement for total joint arthroplasty (TJA). The purpose of this study is to quantify the time spent during the different phases of TJA care relative to the benchmarks used by the Centers for Medicare and Medicaid Services.Methods: We retrospectively reviewed all patients captured in our institutional joint database between January 1, 2014, and December 31, 2018. Four phases of care were assessed: (1) preoperative period following the decision to proceed with TJA and leading to the day before surgery, (2) immediate 24 hours preceding surgery (preservice time), (3) operative time from skin incision to dressing application (intraservice time), and (4) postoperative work including day of surgery and the following 90 days.Results: A total of 666 procedures were analyzed (379 total hip arthroplasties and 287 total knee arthroplasties). The mean preoperative care coordination, preservice, intraservice, immediate postservice, and 91-day global period times were 21.9 ± 10, 84.1, 114 ± 24, 35, and 150 ± 37 minutes, respectively. Except for a slightly higher preoperative time associated with Medicare coverage (P = .031), there were no differences in the other phases of care by payer type. There were no temporal differences between 2014 and 2017. However, in 2018, there were significant increases in preoperative and intraservice times (6 and 20 minutes, respectively, P < .001) which were accompanied with a significant decrease in postoperative service time (34 minutes, P < .001).Conclusion: Even when performing TJA under the most optimal conditions, the overall time has remained stable over the past 5 years and consistent with current benchmarks. [ABSTRACT FROM AUTHOR]- Published
- 2020
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43. Patient-Reported Outcome Measures are not a Valid Proxy for Patient Satisfaction in Total Joint Arthroplasty.
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Halawi, Mohamad J., Jongbloed, Walter, Baron, Samuel, Savoy, Lawrence, Cote, Mark P., and Lieberman, Jay R.
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Background: Patient-reported outcome measures (PROMs) are increasingly used as quality benchmarks in total joint arthroplasty. The objective of this study is to investigate whether PROMs correlate with patient satisfaction, which is arguably the most important and desired outcome.Methods: Our institutional joint database was queried for patients who underwent primary, elective, unilateral total joint arthroplasty. Eligible patients were asked to complete a satisfaction survey at final follow-up. Correlation coefficients (R) were calculated to quantify the relationship between patient satisfaction and prospectively collected PROMs. We explored a wide range of PROMs including Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Short Form-12, Oxford Hip Score, Knee Society Clinical Rating Score (KSCRS), Single Assessment Numerical Evaluation, and University of California Los Angeles activity level rating.Results: In general, there was only weak to moderate correlation between patient satisfaction and PROMs. Querying the absolute postoperative scores had higher correlation with patient satisfaction compared to either preoperative scores or net changes in scores. The correlation was higher with disease-specific PROMs (WOMAC, Oxford Hip Score, KSCRS) compared to general health (Short Form-12), activity level (University of California Los Angeles activity level rating), or perception of normalcy (Single Assessment Numerical Evaluation). Within disease-specific PROMs, the pain domain consistently carried the highest correlation with patient satisfaction (WOMAC pain subscale, R = 0.45, P < .001; KSCRS pain subscale, R = 0.49, P < .001).Conclusion: There is only weak to moderate correlation between PROMs and patient satisfaction. PROMs alone are not the optimal way to evaluate patient satisfaction. We recommend directly querying patients about satisfaction and using shorter PROMs, particularly disease-specific PROMs that assess pain perception to better gauge patient satisfaction. [ABSTRACT FROM AUTHOR]- Published
- 2020
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44. Adherence to the American Academy of Orthopaedic Surgeons Clinical Practice Guidelines for Nonoperative Management of Knee Osteoarthritis.
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Meiyappan, Karthik P., Cote, Mark P., Bozic, Kevin J., and Halawi, Mohamad J.
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Background: The American Academy of Orthopaedic Surgeons (AAOS) has published evidence-based Clinical Practice Guidelines (CPGs) for the nonarthroplasty management of knee osteoarthritis (OA). The purpose of this study is to determine how closely our orthopedic providers adhered to the recommendations included in those CPGs.Methods: We retrospectively reviewed 1096 consecutive ambulatory visits with primary diagnosis of knee OA at a single center. Demographic, radiographic, and treatment information was collected. The primary outcome was the frequency of agreement between our treatment recommendations and the AAOS CPGs. A secondary outcome was the associated costs of care.Results: The total number of interventions generated during the visits was 1955. Adherence to the AAOS guidelines was 65% (362/557), 60% (226/377), and 40% (413/1021) in new/never treated, new/previously treated, and return patients, respectively. Intra-articular injection with either corticosteroids or hyaluronic acid was the most common intervention (32%) followed by physical therapy (29%). As the severity of OA increased, adherence to the AAOS guidelines decreased (61%, 60%, 54%, and 49% for Kellgren-Lawrence grades I through IV, respectively). The estimated annual costs associated with our treatment recommendations were $2,403,543.18, of which $1,206,757.8 (50.2%) was supported by evidence. The most expensive treatment intervention was intra-articular hyaluronic acid injection, which carried a strong evidence against its use.Conclusion: Adherence to the recommendations contained within the AAOS CPGs was modest regardless of the Kellgren-Lawrence grade or history of treatment. Given the size of the affected patient population, there is a need for uniformly accepted guidelines to clarify the role and timing of the different treatment interventions. CPGs should be combined with education, patient engagement, and shared decision-making to minimize variation in treatment patterns, improve patient outcomes, and lower overall costs of care. [ABSTRACT FROM AUTHOR]- Published
- 2020
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45. Biomechanical Effect of Superior Capsule Reconstruction Using a 3-mm and 6-mm Thick Acellular Dermal Allograft in a Dynamic Shoulder Model.
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Scheiderer, Bastian, Kia, Cameron, Obopilwe, Elifho, Johnson, Jeremiah D., Cote, Mark P., Imhoff, Florian B., Dyrna, Felix, Beitzel, Knut, Imhoff, Andreas B., Adams, Christopher R., Mazzocca, Augustus D., and Morikawa, Daichi
- Abstract
Purpose: To biomechanically compare the effect of superior capsule reconstruction (SCR) using a 3- and 6-mm thick acellular dermal allograft for the treatment of irreparable rotator cuff tears.Methods: Eight fresh-frozen cadaveric shoulders were tested using a dynamic shoulder model. Maximum abduction angle (MAA), glenohumeral superior translation (ghST), subacromial peak contact pressure (sPCP), and cumulative deltoid force (cDF) were compared among 4 conditions: (1) intact shoulder, (2) simulated irreparable rotator cuff tear (RCT), (3) SCR using a 3-mm-thick acellular dermal allograft, (4) SCR using a 6-mm-thick acellular dermal allograft.Results: Compared with the intact state, simulated irreparable RCTs significantly decreased MAA (P < .001), while significantly increasing ghST (P = .001), sPCP (P < .001), and cDF (P < .001). SCR with a 3-mm-thick graft significantly increased MAA (P = .01) and decreased ghST (P = .01) compared with the RCT state, however, showed similar sPCP and cDF. Compared with the torn state, SCR with a 6-mm-thick graft significantly increased MAA (P < .001) and significantly decreased ghST (P < .001), sPCP (P < .001), and cDF (P = .001). Using a 6-mm-thick graft demonstrated similar MAA, ghST, sPCP, and cDF compared with the intact state. When comparing the 3-mm to the 6-mm thick graft, significant differences were found in ghST (P = .03), sPCP (P < .001), and cDF (P = .02).Conclusions: SCR with a 6-mm-thick acellular dermal allograft better restored normal glenohumeral joint position and forces compared with a 3-mm-thick graft for the treatment of irreparable RCTs.Clinical Relevance: Graft thickness may affect the clinical success following SCR with commercially available dermal allografts. Using a thicker (>3 mm) graft was able to biomechanically better restore native glenohumeral joint properties. [ABSTRACT FROM AUTHOR]- Published
- 2020
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46. Degenerative Meniscus Lesions: An Expert Consensus Statement Using the Modified Delphi Technique.
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Hohmann, Erik, Angelo, Richard, Arciero, Robert, Bach, Bernard R., Cole, Brian, Cote, Mark, Farr, Jack, Feller, Julian, Gelbhart, Brad, Gomoll, Andreas, Imhoff, Andreas, LaPrade, Robert, Mandelbaum, Bert R., Marx, Robert G., Monllau, Juan C., Noyes, Frank, Parker, David, Rodeo, Scott, Sgaglione, Nicholas, and Shea, Kevin
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Purpose: The purpose of this study was to perform an evidence-based, expert consensus survey using the Delphi panel methodology to develop recommendations for the treatment of degenerative meniscus tears.Methods: Twenty panel members were asked to respond to 10 open-ended questions in rounds 1 and 2. The results of the first 2 rounds served to develop a Likert-style questionnaire for round 3. In round 4, the panel members outside consensus were contacted and asked to either change their score in view of the group's response or argue their case. The level of agreement for round 4 was defined as 80%.Results: There was 100% agreement on the following items: insidious onset, physiological part of aging, tears often multiplanar, not all tears cause symptoms, outcomes depend on degree of osteoarthritis, obesity is a predictor of poor outcome, and younger patients (<50 years) have better outcomes. There was between 90% and 100% agreement on the following items: tears are nontraumatic, radiographs should be weightbearing, initial treatment should be conservative, platelet-rich plasma is not a good option, repairable and peripheral tears should be repaired, microfracture is not a good option for chondral defects, the majority of patients obtain significant improvement and decrease in pain with surgery but results are variable, short-term symptoms have better outcomes, and malalignment and root tears have poor outcomes.Conclusions: This consensus statement agreed that degenerative meniscus tears are a normal part of aging. Not all tears cause symptoms and, when symptomatic, they should initially be treated nonoperatively. Repairable tears should be repaired. The outcome of arthroscopic partial meniscectomy depends on the degree of osteoarthritis, the character of the meniscus lesion, the degree of loss of joint space, the amount of malalignment, and obesity. The majority of patients had significant improvement, but younger patients and patients with short-term symptoms have better outcomes.Level Of Evidence: Level V - expert opinion. [ABSTRACT FROM AUTHOR]- Published
- 2020
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47. Depression Treatment Is Not Associated With Improved Patient-Reported Outcomes Following Total Joint Arthroplasty.
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Halawi, Mohamad J., Gronbeck, Christian, Savoy, Lawrence, Cote, Mark P., and Lieberman, Jay R.
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Background: The objective of this study was to investigate if there were differences in disease-specific, overall health, and activity outcomes after total joint arthroplasty (TJA) between treated and untreated depressed patients.Methods: Patients who underwent primary, elective, unilateral TJA were divided into 3 groups based on self-reported history of depression and treatment at the time of surgery: 1) patients without depression, 2) patients with treated depression, and 3) patients with untreated depression. The primary outcomes were the differences in SF-12 PCS, SF-12 MCS, WOMAC, and UCLA activity rating scale up to 12 months postoperatively. A secondary outcome was the effect of depression treatment on patients' perception of experiencing limitation in their activities due to depression. Univariate and mixed-effects model analyses were performed to control for potential confounding factors.Results: The prevalence of depression was 189/749 (25%). Compared to patients with treated depression, untreated patients had lower baseline SF-12 MCS (P < .001) and were more likely to have Medicaid insurance (P < .001). After controlling for potential confounding factors, there were no differences in either the absolute scores or net changes in any of the assessed outcomes at 12 months postoperatively among depressed patients regardless of treatment (P > .05). In addition, depression treatment did not affect patients' perception of activity limitation (P = .412).Conclusion: Although it is clear that depression adversely impacts patient outcomes in primary TJA, treatment does not appear to mitigate this negative effect. Depression treatment does not necessarily imply resolution of depressive symptoms. Future studies should explore alternative interventions to reduce the health-related consequences of depression to optimize the outcomes of TJA. [ABSTRACT FROM AUTHOR]- Published
- 2020
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48. High Clinical Failure Rate After Latissimus Dorsi Transfer for Revision Massive Rotator Cuff Tears.
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Muench, Lukas N, Kia, Cameron, Williams, Ariel A, Avery, Daniel M 3rd, Cote, Mark P, Reed, Nicholas, Arciero, Robert A, Chandawarkar, Rajiv, and Mazzocca, Augustus D
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Purpose: To evaluate the clinical success rate, along with risk factors for failure, in patients undergoing latissimus dorsi transfer for the treatment of massive, irreparable, previously failed rotator cuff tears.Methods: We performed a retrospective chart review of prospectively collected data from an institutional shoulder outcome registry. All patients who underwent latissimus dorsi transfer for previously failed rotator cuff repair between 2006 and 2013 with a minimum follow-up period of 1 year were included in the study. The indications for inclusion were large (≥2 tendons), retracted, chronic rotator cuff tears with fatty infiltration or atrophy for which prior surgical repair had failed. Preoperative and postoperative American Shoulder and Elbow Surgeons (ASES) and Simple Shoulder Test scores were collected, along with postoperative Single Assessment Numerical Evaluation scores. Complications and clinical failures (Δ in ASES score <17) were recorded. Patient demographic and tear characteristics were evaluated as potential risk factors for failure.Results: A total of 22 patients (mean age, 53 ± 6 years) were included in the study, with a mean follow-up time of 3.4 ± 1.1 years. Over 63% of patients (n = 14) reported undergoing 2 or more prior failed rotator cuff repairs. Patients undergoing latissimus dorsi transfer showed significant improvements in ASES scores (from 35.2 ± 21.9 preoperatively to 55.8 ± 22.9 postoperatively, P = .001), Simple Shoulder Test scores (from 3.5 ± 3.1 preoperatively to 5.2 ± 3.4 postoperatively, P = .002), and pain scores (from 5.9 ± 2.8 preoperatively to 4.6 ± 4.3 postoperatively, P = .002) at final follow-up. The complication rate after latissimus transfer was 27%. The rate of revision to reverse total shoulder arthroplasty was 13.6% (n = 3) after a mean of 2.7 years, and the clinical failure rate was 41% (n = 9) at final follow-up. An acromiohumeral interval of less than 7 mm (P = .04) and high-grade fatty infiltration (grade 3 or greater, P = .004) were significant preoperative risk factors for clinical failure.Conclusions: Latissimus dorsi tendon transfer resulted in a clinical failure rate of 41% and complication rate of 27%, with an acromiohumeral interval of less than 7 mm and high-grade fatty infiltration being associated with postoperative failure.Level Of Evidence: Level IV. [ABSTRACT FROM AUTHOR]- Published
- 2020
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49. Reconstruction of the Acromioclavicular Ligament Complex Using Dermal Allograft: A Biomechanical Analysis.
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Morikawa, Daichi, Mazzocca, Augustus D, Obopilwe, Elifho, Cote, Mark P, Kia, Cameron, Johnson, Jeremiah D, Imhoff, Florian B, and Scheiderer, Bastian
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Purpose: To analyze the posterior translational and rotational stability of the acromioclavicular (AC) joint following reconstruction of the superior acromioclavicular ligament complex (ACLC) using dermal allograft.Methods: Six fresh-frozen cadaveric shoulders were used (mean age of 65.3 ± 6.9 years). The resistance force against posterior translation (10 mm) and torque against posterior rotation (20°) was measured. Specimens were first tested with both the intact ACLC and coracoclavicular ligaments. The ACLC and coracoclavicular ligaments were then transected so simulate a Type III/V AC joint dislocation. Each specimen then underwent 3 testing conditions, performed in the following order: (1) ACLC patch reconstruction alone, (2) ACLC patch with an anatomic coracoclavicular reconstruction (ACCR) using semitendinosus allograft, and (3) the transected ACLC with an ACCR only. Differences in posterior translational and rotational torque across testing conditions were analyzed with a one-way repeated analysis of variance analysis.Results: Mean resistance against posterior translation in the intact condition was 65.76 ± 23.8 N. No significant difference found between the intact condition compared with specimens with the ACLC-patch only (44.2 ± 11.3 N, P = .06). The ACCR technique, when tested alone, had significantly less posterior translational resistance compared with the intact condition (38.5 ± 8.94 N, P = .008). ACLC patch in combination with an ACCR was closest in restoring native posterior translation (57.1 ± 19.2 N, P = .75). For rotational resistance, only the addition of the ACLC patch with an ACCR (0.51 ± 0.07 N-m) demonstrated similar torque compared with the intact joint (0.89 ± 0.5 N-m, P = .06).Conclusions: The ACLC-patch plus ACCR technique was able to closest restore the percent of normal posterior translational and rotational stability.Clinical Relevance: Recurrent posterior instability of the AC joint is a potential complication after coracoclavicular reconstruction surgery. In the in vitro setting, this study demonstrated increased AC joint stability with the addition of an ACLC reconstruction using dermal allograft. [ABSTRACT FROM AUTHOR]- Published
- 2020
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50. Examining the Potency of Subacromial Bursal Cells as a Potential Augmentation for Rotator Cuff Healing: An In Vitro Study.
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Morikawa, Daichi, Johnson, Jeremiah D., Kia, Cameron, McCarthy, Mary Beth R., Macken, Craig, Bellas, Nicholas, Baldino, Joshua B., Cote, Mark P., and Mazzocca, Augustus D.
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Purpose: To compare the potency of mesenchymal stem cells between the cells derived from the subacromial bursa to concentrated bone marrow aspirate (cBMA) taken from patients undergoing rotator cuff (RC) repair.Methods: Subacromial bursa and cBMA were harvested arthroscopically from 13 patients (age 57.4 ± 5.2 years, mean ± standard deviation) undergoing arthroscopic primary RC repair. Bone marrow was aspirated from the proximal humerus and concentrated using an automated system (Angel System; Arthrex). Subacromial bursa was collected from 2 sites (over the RC tendon and muscle) and digested with collagenase to isolate a single cellular fraction. Proliferation, number of colony-forming units, differentiation potential, and gene expression were compared among the cells derived from each specimen.Results: The cells derived from subacromial bursa showed significantly higher proliferation compared with the cells derived from cBMA after 5, 7, and 10 days (P = .018). Regarding colony-forming units, the subacromial bursa had significantly more colonies than cBMA (P = .002). Subacromial bursal cells over the RC tendon produced significantly more colonies than cells over both the RC muscle and cBMA (P = .033 and P = .028, respectively). Moreover, when compared with cBMA, cells derived from subacromial bursa showed significantly higher differentiation ability and higher gene expression indicative of chondrogenesis, osteogenesis, and adipogenesis.Conclusion: The subacromial bursa is an easily accessible tissue that can be obtained during RC repair, with significant pluripotent stem cell potency for tendon healing. Compared with cBMA taken from the proximal humerus, bursal cells showed significantly increased differentiation ability and gene expression over time.Clinical Relevance: Failed RC repairs have been partly attributed to a poor healing environment. Biologic augmentation of the repair site may help increase healing potential and incorporation of the cuff at the tendon-bone interface. [ABSTRACT FROM AUTHOR]- Published
- 2019
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