Search

Abstract. Objectives:. To develop and validate a prediction model for a deep surgical site infection (SSI) after fixation of a tibial plateau or pilon fracture. Design:. Pooled data from 2 randomized trials (VANCO and OXYGEN). Setting:. Fifty-two US trauma centers. Patients:. In total, 1847 adult patients with operatively treated tibial plateau or pilon fractures who met criteria for a high risk of infection. Intervention:. We considered 13 baseline patient characteristics and developed and externally validated prediction models using 3 approaches (logistic regression, stepwise elimination, and machine learning). Main Outcomes and Measures:. The primary prediction model outcome was a deep SSI requiring operative debridement within 182 days of definitive fixation. Our primary prognostic performance metric for evaluating the models was area under the receiver operating characteristic curve (AUC) with clinical utility set at 0.7. Results:. Deep SSI occurred in 75 VANCO patients (8%) and in 56 OXYGEN patients (6%). The machine learning model for VANCO (AUC = 0.65) and stepwise elimination model for OXYGEN (AUC = 0.62) had the highest internal validation AUCs. However, none of the external validation AUCs exceeded 0.64 (range, 0.58 to 0.64). Conclusions:. The predictive models did not reach the prespecified clinical utility threshold. Our models' inability to distinguish high-risk from low-risk patients is likely due to strict eligibility criteria and, therefore, homogeneous patient populations.

Abstract. Objectives:. To determine venous thromboembolism (VTE) testing patterns in an orthopaedic trauma population and to evaluate for differences in VTE surveillance by prophylaxis regimen through a secondary analysis of the ADAPT trial. Design:. Prospective randomized trial. Setting:. Level I trauma center. Patients:. Three hundred twenty-nine adult (18 years and older) trauma patients presenting with an operative extremity fracture proximal to the metatarsals/carpals or any pelvic or acetabular fracture requiring VTE prophylaxis. Intervention:. VTE imaging studies recorded within 90 days post injury. Main Outcome Measurements:. Percentage of patients tested for VTE were compared between treatment groups using Fisher's exact test. Subsequently, multivariable regression was used to determine patient factors significantly associated with risk of receiving a VTE imaging study. Results:. Sixty-seven patients (20.4%) had VTE tests ordered during the study period. Twenty (29.9%) of these 67 patients with ordered VTE imaging tests had a positive finding. No difference in proportion of patients tested for VTE by prophylaxis regimen (18.8% on aspirin vs. 22.0% on LMWH, P = 0.50) was observed. Factors associated with increased likelihood of VTE testing included White race (adjusted odds ratio [aOR]: 2.61, 95% CI: 1.26–5.42), increased Injury Severity Score (aOR for every 1-point increase: 1.10, 95% CI: 1.05–1.15), and lower socioeconomic status based on the Area Deprivation Index (aOR for every 10-point increase: 1.14, 95% CI: 1.00–1.30). Conclusions:. VTE surveillance did not significantly differ by prophylaxis regimen. Patient demographic factors including race, injury severity, and socioeconomic status were associated with differences in VTE surveillance. Level of Evidence:. Level I, Therapeutic.

Introduction When considering treatment options for geriatric patients with lower extremity fractures, little is known about which outcomes are prioritized by patients. This study aimed to determine the patient preferences for outcomes after a geriatric lower extremity fracture. Materials and Methods We administered a discrete choice experiment survey to 150 patients who were at least 60 years of age and treated for a lower extremity fracture at a Level I trauma center. The discrete choice experiment presented study participants with 8 sets of hypothetical outcome comparisons, including joint preservation (yes or no), risk of reoperation at 6 months and 24 months, postoperative weightbearing status, disposition, and function as measured by return to baseline walking distance. We estimated the relative importance of these potential outcomes using multinomial logit modeling. Results The strongest patient preference was for maintained function after treatment (59%, P < .001), followed by reoperation within 6 months (12%, P < .001). Although patients generally favored joint preservation, patients were willing to change their preference in favor of joint replacement if it increased function (walking distance) by 13% (SE, 66%). Reducing the short-term reoperation risk (12%, P < .001) was more important to patients than reducing long-term reoperation risk (4%, P = .33). Disposition and weightbearing status were lesser priorities to patients (9%, P < .001 and 7%, P < .001, respectively). Discussion After a lower extremity fracture, geriatric patients prioritized maintained walking function. Avoiding short-term reoperation was more important than avoiding long-term reoperation. Joint preservation through fracture fixation was the preferred treatment of geriatric patients unless arthroplasty or arthrodesis provides a meaningful functional benefit. Hospital disposition and postoperative weightbearing status were less important to patients than the other included outcomes. Conclusions Geriatric patients strongly prioritize function over other outcomes after a lower extremity fracture.

Abstract. Objectives:. Patient engagement in the design and implementation of clinical trials is necessary to ensure that the research is relevant and responsive to patients. The PREP-IT trials, which include 2 pragmatic trials that evaluate different surgical preparation solutions in orthopaedic trauma patients, followed the patient-centered outcomes research (PCOR) methodology throughout the design, implementation, and conduct. We conducted a substudy within the PREP-IT trials to explore participants' experiences with trial participation. Methods:. At the final follow-up visit (12 months after their fracture), patients participating in the PREP-IT trials were invited to participate in the substudy. After providing informed consent, participants completed a questionnaire that asked about their experience and satisfaction with participating in the PREP-IT trials. Descriptive statistics are used to report the findings. Results:. Four hundred two participants participated in the substudy. Most participants (394 [98%]) reported a positive experience, and 376 (94%) participants felt their contributions were appreciated. The primary reasons for participation were helping future patients with fracture (279 [69%]) and to contribute to science (223 [56%]). Two hundred seventeen (46%) participants indicated that their decision to participate was influenced by the minimal time commitment. Conclusions:. Most participants reported a positive experience with participating in the PREP-IT trials. Altruism was the largest motivator for participating in this research. Approximately half of the participants indicated that the pragmatic, low-participant burden design of the trial influenced their decision to participate. Meaningful patient engagement, a pragmatic, and low-burden protocol led to high levels of participant satisfaction.

Abstract Background Approximately 1 in 10 patients with a surgically treated open fracture will develop a surgical site infection. The Aqueous-PREP trial will investigate the effect of 10% povidone-iodine versus 4% chlorhexidine in aqueous antiseptic solutions in reducing infections after open fracture surgery. The study protocol was published in April 2020. Methods and design The Aqueous-PREP trial is a pragmatic, multicenter, open-label, randomized multiple period cluster crossover trial. Each participating cluster is randomly assigned in a 1:1 ratio to provide 1 of the 2 study interventions on all eligible patients during a study period. The intervention periods are 2 months in length. After completing a 2-month period, the participating cluster crosses over to the alternative intervention. We plan to enroll a minimum of 1540 patients at 14 sites. Results The primary outcome is surgical site infection guided by the Centers for Disease Control and Prevention’s National Healthcare Safety Network reporting criteria (2017). All participants’ surgical site infection surveillance period will end 30 days after definitive fracture management surgery for superficial infections and 90 days after definitive fracture management surgery for deep incisional or organ/space infections [1]. The secondary outcome is an unplanned fracture-related reoperation within 12 months of the fracture. Conclusion This manuscript serves as the formal statistical analysis plan (version 1.0) for the Aqueous-PREP trial. The statistical analysis plan was completed on February 28, 2022.

Aims: Bone turnover markers (BTMs) follow distinct trends after fractures and limited evidence suggests differential levels in BTMs in patients with delayed healing. The effect of vitamin D, and other factors that influence BTMs and fracture healing, is important to elucidate the use of BTMs as surrogates of fracture healing. We sought to determine whether BTMs can be used as early markers of delayed fracture healing, and the effect of vitamin D on BTM response after fracture. Methods: A total of 102 participants aged 18 to 50 years (median 28 years (interquartile range 23 to 35)), receiving an intramedullary nail for a tibial or femoral shaft fracture, were enrolled in a randomized controlled trial comparing vitamin D3 supplementation to placebo. Serum C-terminal telopeptide of type I collagen (CTX; bone resorption marker) and N-terminal propeptide of type I procollagen (P1NP; bone formation marker) were measured at baseline, six weeks, and 12 weeks post-injury. Clinical and radiological fracture healing was assessed at three months. Results: CTX and P1NP concentrations peaked at six weeks in all groups. Elevated six-week CTX and P1NP were associated with radiological healing at 12 weeks post-injury (odds ratio (OR) 10.5; 95% confidence interval 2.71 to 53.5, p = 0.002). We found no association between CTX or P1NP and functional healing. Baseline serum 25(OH)D showed a weak inverse relationship with P1NP (p = 0.036) and CTX (p = 0.221) at 12 weeks, but we observed no association between vitamin D supplementation and either BTM. Conclusion: Given the association between six-week BTM concentrations and three-month radiological fracture healing, CTX and P1NP appear to be potential surrogate markers of fracture healing. Cite this article: Bone Joint Res 2022;11(4):239–250.

Aims There is increasing evidence to support the use of topical antibiotics to prevent surgical site infections. Although previous research suggests a minimal nephrotoxic risk with a single dose of vancomycin powder, fracture patients often require multiple procedures and receive additional doses of topical antibiotics. We aimed to determine if cumulative doses of intrawound vancomycin or tobramycin powder for infection prophylaxis increased the risk of drug-induced acute kidney injury (AKI) among fracture patients. Methods This cohort study was a secondary analysis of single-centre Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma (PREP-IT) trial data. We included patients with a surgically treated appendicular fracture. The primary outcome was drug-induced AKI. The odds of AKI per gram of vancomycin or tobramycin powder were calculated using Bayesian regression models, which adjusted for measured confounders and accounted for the interactive effects of vancomycin and tobramycin. Results Of the 782 included patients (mean age 48 years (SD 20); 59% male), 83% (n = 648) received at least one vancomycin dose (cumulative range 1 to 12 g). Overall, 45% of the sample received at least one tobramycin dose (cumulative range 1.2 to 9.6 g). Drug-induced AKI occurred in ten patients (1.2%). No association was found between the cumulative dose of vancomycin and drug-induced AKI (odds ratio (OR) 1.08 (95% credible interval (CrI) 0.52 to 2.14)). Additional doses of tobramycin were associated with a three-fold increase in the adjusted odds of drug-induced AKI (OR 3.66 (95% CrI 1.71 to 8.49)). Specifically, the risk of drug-induced AKI rose substantially after 4.8 g of tobramycin powder (7.5% (95% CrI 1.0 to 35.3)). Conclusion Cumulative doses of vancomycin were not associated with an increased risk of drug-induced AKI among fracture patients. While the risk of drug-induced AKI remains less than 4% with three or fewer 1.2 g tobramycin doses, the estimated risk increases substantially to 8% after four cumulative doses. Level of evidence: Therapeutic Level III Cite this article: Bone Jt Open 2022;3(4):284–290.

Aims To evaluate the impact of negative pressure wound therapy (NPWT) on the odds of having deep infections and health-related quality of life (HRQoL) following open fractures. Methods Patients from the Fluid Lavage in Open Fracture Wounds (FLOW) trial with Gustilo-Anderson grade II or III open fractures within the lower limb were included in this secondary analysis. Using mixed effects logistic regression, we assessed the impact of NPWT on deep wound infection requiring surgical intervention within 12 months post-injury. Using multilevel model analyses, we evaluated the impact of NPWT on the Physical Component Summary (PCS) of the 12-Item Short-Form Health Survey (SF-12) at 12 months post-injury. Results After applying inverse probability treatment weighting to adjust for the influence of injury characteristics on type of dressing used, 1,322 participants were assessed. The odds of developing a deep infection requiring operative management within 12 months of initial surgery was 4.52-times higher in patients who received NPWT compared to those who received a standard wound dressing (95% confidence interval (CI) 1.84 to 11.12; p = 0.001). Overall, 1,040 participants were included in our HRQoL analysis, and those treated with NPWT had statistically significantly lower mean SF-12 PCS post-fracture (p < 0.001). These differences did not reach the minimally important difference for the SF-12 PCS. Conclusion Our analysis found that patients treated with NPWT had higher odds of developing a deep infection requiring operative management within 12 months post-fracture. Due to possible residual confounding with the worst cases being treated with NPWT, we are unable to determine if NPWT has a negative effect or is simply a marker of worse injuries or poor access to early soft-tissue coverage. Regardless, our results suggest that the use of this treatment requires further evaluation. Cite this article: Bone Jt Open 2022;3(3):189–195.

Abstract. Objectives:. Surgical site infections in orthopaedic trauma are a significant problem with meaningful patient and health care system–level consequences. Direct application of antibiotics to the surgical field has many potential benefits in reducing surgical site infections. However, to date, the data regarding the local administration of antibiotics have been mixed. This study reports on the variability of prophylactic vancomycin powder use in orthopaedic trauma cases across 28 centers. Methods:. Intrawound topical antibiotic powder use was prospectively collected within three multicenter fracture fixation trials. Fracture location, Gustilo classification, recruiting center, and surgeon information were collected. Differences in practice patterns across recruiting center and injury characteristics were tested using chi-square statistic and logistic regression. Additional stratified analyses by recruiting center and individual surgeon were performed. Results:. A total of 4941 fractures were treated, and vancomycin powder was used in 1547 patients (31%) overall. Local administration of vancomycin powder was more frequent in open fractures 38.8% (738/1901) compared with closed fractures 26.6% (809/3040) (P < 0.001). However, the severity of the open fracture type did not affect the rate at which vancomycin powder was used (P = 0.11). Vancomycin powder use varied substantially across the clinical sites (P < 0.001). At the surgeon level, 75.0% used vancomycin powder in less than one-quarter of their cases. Conclusions:. Prophylactic intrawound vancomycin powder remains controversial with varied support throughout the literature. This study demonstrates wide variability in its use across institutions, fracture types, and surgeons. This study highlights the opportunity for increased practice standardization for infection prophylaxis interventions. Level of Evidence:. Prognostic—III.

ABSTRACT Nearly half of adult fracture patients are vitamin D deficient (serum 25‐hydroxyvitamin D [25(OH)D] levels

Abstract. Bone devitalization is believed to be a critical determinant of complications such as infection or nonunion. However, intraoperative assessment of bone devitalization, particularly in open fractures and infections, remains highly subjective resulting in variation in treatment. Optical imaging tools, particularly dynamic contrast-enhanced fluorescence imaging, can provide real-time, intraoperative assessment of bone and soft tissue perfusion, which informs the tissues' ability to heal and fight infection. We describe a novel technique to apply indocyanine green–based fluorescence imaging, using a device that is frequently used in the operating room to assess skin or flap perfusion in plastic surgery, to assess bone and deep tissue perfusion in three pertinent cases: (1) a chronic infection/nonunion after a Gustilo type 3A tibia fracture (patient 1), (2) an acute Gustilo type 3C tibia open fracture with extensive degloving/soft tissue stripping (patient 2), and (3) an atrophic nonunion of the humerus (patient 3). In all three cases, fluorescence imaging (both time-specific fluorescence and maximum fluorescence) and derived kinetic maps of time-to-peak, ingress slope, and egress slope demonstrated clear spatial variation in perfusion that corresponded to the patient pathogenesis. The impact of this information on patient outcome will need to be evaluated in future clinical trials; however, these cases demonstrate in principle that optical imaging information has the potential to inform surgical practice, reduce the variation in treatment, and improve outcomes observed in these challenging patients.

Background: At the initiation of the COVID-19 pandemic, restrictions forced researchers to decide whether to continue their ongoing clinical trials. The PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities) trial is a pragmatic cluster-randomized crossover trial in patients with open and closed fractures. PREPARE was enrolling over 200 participants per month at the initiation of the pandemic. We aim to describe how the COVID-19 research restrictions affected participant enrollment. Methods: The PREPARE protocol permitted telephone consent, however, sites were obtaining consent in-person. To continue enrollment after the initiation of the restrictions participating sites obtained ethics approval for telephone consent scripts and the waiver of a signature on the consent form. We recorded the number of sites that switched to telephone consent, paused enrollment, and the length of the pause. We used t-tests to compare the differences in monthly enrollment between July 2019 and November 2020. Results: All 19 sites quickly implement telephone consent. Fourteen out of nineteen (73.6%) sites paused enrollment due to COVID-19 restrictions. The median length of enrollment pause was 46.5 days (range, 7–121 days; interquartile range, 61 days). The months immediately following the implementation of restrictions had significantly lower enrollment. Conclusion: A pragmatic design allowed sites to quickly adapt their procedures for obtaining informed consent via telephone and allowed for minimal interruptions to enrollment during the pandemic.

Abstract. Objective:. To quantify patient preferences towards time to return to driving relative to compromised reaction time and potential complication risks. Design:. Cross-sectional discrete choice experiment. Setting:. Academic trauma center. Patients:. Ninety-six adult patients with an operative lower extremity fracture from December 2019 through December 2020. Intervention:. None. Main Outcome Measurement:. Patient completed a discrete choice experiment survey consisting of 12 hypothetical return to driving scenarios with varied attributes: time to return to driving (range: 1 to 6 months), risk of implant failure (range: 1% to 12%), pain upon driving return (range: none to severe), and driving safety measured by braking distance (range: 0 to 40 feet at 60 mph). The relative importance of each attribute is reported on a scale of 0% to 100%. Results:. Patients most valued a reduced pain level when resuming driving (62%), followed by the risk of implant failure (17%), time to return to driving (13%), and braking safety (8%). Patients were indifferent to returning to driving at 1 month (median utility: 28, interquartile range [IQR] −31 to 80) or 2 months (median utility: 59, IQR: 41 to 91) postinjury. Conclusion:. Patients with lower extremity injuries demonstrated a willingness to forego earlier return to driving if it might mean a decrease in their pain level. Patients are least concerned about their driving safety, instead placing higher value on their own pain level and chance of implant failure. The findings of this study are the first to rigorously quantify patient preferences toward a return to driving and heterogeneity in patient preferences. Level of Evidence:. V

Abstract Background Preoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures. Methods Two orthopedic trauma centers participated in this pilot study. Each of these clinical sites was randomized to a starting solution (povidone-iodine solution or chlorhexidine gluconate) then subsequently crossed over to the other treatment after 2 months. During the 4-month enrollment phase, we assessed compliance, enrollment rates, participant follow-up, and accurate documentation of the primary clinical outcome. Feasibility outcomes included (1) the implementation of the interventions during a run-in period; (2) enrollment of participants during two 2-month enrollment phases; (3) application of the trial interventions as per the cluster randomization crossover scheme; (4) participant follow-up; and (5) accurate documentation of the primary outcome (surgical site infection). Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables. Corresponding 95% confidence intervals (CIs) were also reported. Results All five of the criteria for feasibility were met. During the run-in phase, all 18 of the eligible patients identified at the two clinical sites received the correct cluster-assigned treatment. A total of 135 patients were enrolled across both sites during the 4-month recruitment phase, which equates to 92% (95% CI 85.9 to 96.4%) of eligible patients being enrolled. Compliance with the assigned treatment in the pilot study was 98% (95% CI 93.5 to 99.8%). Ninety-eight percent (95% CI 93.5 to 99.8%) of participants completed the 90-day post-surgery follow-up and the primary outcome (SSI) was accurately documented for 100% (95% CI 96.6 to 100.0%) of the participants. Conclusions These results confirm the feasibility of a definitive study comparing antiseptic solutions using a cluster randomized crossover trial design. Building upon the infrastructure established during the pilot phase, a definitive study has been successfully initiated. Trial registration ClincialTrials.gov , number NCT03385304 . Registered December 28, 2017.

Abstract Background In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics. Methods The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics. Results We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists. Conclusions The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics. Trial registration Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).

Abstract Background This study aimed to address the current limitations of the use of composite endpoints in orthopaedic trauma research by quantifying the relative importance of clinical outcomes common to orthopaedic trauma patients and use those values to develop a patient-centered composite endpoint weighting technique. Methods A Best-Worst Scaling choice experiment was administered to 396 adult surgically-treated fracture patients. Respondents were presented with ten choice sets, each consisting of three out of ten plausible clinical outcomes. Hierarchical Bayesian modeling was used to determine the utilities associated with the outcomes. Results Death was the outcome of greatest importance (mean utility = − 8.91), followed by above knee amputation (− 7.66), below knee amputation (− 6.97), severe pain (− 5.90), deep surgical site infection (SSI) (− 5.69), bone healing complications (− 5.20), and moderate pain (− 4.59). Mild pain (− 3.30) and superficial SSI (− 3.29), on the other hand, were the outcomes of least importance to respondents. Conclusion This study revealed that patients’ relative importance towards clinical outcomes followed a logical gradient, with distinct and quantifiable preferences for each possible component outcome. These findings were incorporated into a novel composite endpoint weighting technique.

Abstract Background Observational studies have found that 75% of healthy adult fracture patients (ages 18–50) have serum 25-hydroxyvitamin D (25(OH)D) levels

Abstract Background Femoral neck fractures in patients ≤ 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial. Methods We will conduct a multicenter, concealed randomized controlled pilot study, using a 2 × 2 factorial design in 60 patients aged 18–60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed. Discussion Results of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations. Trial registration The FAITH-2 trial, described as a definitive trial, was registered at ClinicalTrials.gov (NCT01908751) prior to enrollment of the first participant.

Abstract Background Given its role in treating musculoskeletal conditions, rehabilitation medicine may be an important factor in decreasing the use of opioids among injured workers. The primary objective was to determine if increased utilization of rehabilitation services was associated with decreased persistent opioid use among workers’ compensation claimants. The secondary objective was to determine the combined association of rehabilitation service utilization and persistent opioid use with days of work lost due to injury. Methods Using Chesapeake Employers’ Insurance Company claims data from 2008 to 2016, claimants with at least one filled opioid prescription within 90 days of injury were eligible for inclusion. The primary outcome was persistent opioid use, defined as at least one filled opioid prescription more than 90 days from injury. The secondary outcome was days lost due to injury. The primary variable of interest, rehabilitation service utilization, was quantified based on the number of rehabilitation service claims and grouped into five levels (no utilization, and four quartiles - low, medium, high, very high). Results Of the 9596 claimants included, 29% were persistent opioid users. Compared to claimants that did not utilize rehabilitation services, patients with very high rehabilitation utilization were nearly three times more likely (OR: 2.71, 95% CI: 2.28–3.23, p

Introduction: Cluster randomized crossover trials are often faced with a dilemma when selecting an optimal model of consent, as the traditional model of obtaining informed consent from participant's before initiating any trial related activities may not be suitable. We describe our experience of engaging patient advisors to identify an optimal model of consent for the PREP-IT trials. This paper also examines surrogate measures of success for the selected model of consent. Methods: The PREP-IT program consists of two multi-center cluster randomized crossover trials that engaged patient advisors to determine an optimal model of consent. Patient advisors and stakeholders met regularly and reached consensus on decisions related to the trial design including the model for consent. Patient advisors provided valuable insight on how key decisions on trial design and conduct would be received by participants and the impact these decisions will have. Results: Patient advisors, together with stakeholders, reviewed the pros and cons and the requirements for the traditional model of consent, deferred consent, and waiver of consent. Collectively, they agreed upon a deferred consent model, in which patients may be approached for consent after their fracture surgery and prior to data collection. The consent rate in PREP-IT is 80.7%, and 0.67% of participants have withdrawn consent for participation. Discussion: Involvement of patient advisors in the development of an optimal model of consent has been successful. Engagement of patient advisors is recommended for other large trials where the traditional model of consent may not be optimal.

Introduction: Pragmatic trials in comparative effectiveness research assess the effects of different treatment, therapeutic, or healthcare options in clinical practice. They are characterized by broad eligibility criteria and large sample sizes, which can lead to an unmanageable number of participants, increasing the risk of bias and affecting the integrity of the trial. We describe the development of a sampling strategy tool and its use in the PREPARE trial to circumvent the challenge of unmanageable work flow. Methods: Given the broad eligibility criteria and high fracture volume at participating clinical sites in the PREPARE trial, a pragmatic sampling strategy was needed. Using data from PREPARE, descriptive statistics were used to describe the use of the sampling strategy across clinical sites. A Chi-square test was performed to explore whether use of the sampling strategy was associated with a reduction in the number of missed eligible patients. Results: 7 of 20 clinical sites (35%) elected to adopt a sampling strategy. There were 1539 patients excluded due to the use of the sampling strategy, which represents 30% of all excluded patients and 20% of all patients screened for participation. Use of the sampling strategy was associated with lower odds of missed eligible patients (297/4545 (6.5%) versus 341/3200 (10.7%) p

Background:. A noted deficiency in orthopaedic resident education is a lack of intraoperative autonomy; however, no studies exist evaluating this issue. The purpose of this study was to determine whether there is a difference between resident and attending perception of resident competency and autonomy during arthroscopic rotator cuff repairs and whether increased perceived competency leads to more autonomy. Methods:. This study included 21 orthopaedic residents and 7 attendings from a single residency program. A survey was developed that included the previously validated Ottawa Surgical Competency Operating Room Evaluation (O-SCORE) and implemented novel arthroscopic rotator cuff repair questions concerning 5 key procedural steps determined by attendings. The survey assessed resident and attending perception of percent opportunity given and percent completed of each step and whether the resident could complete the surgery independently. Paired comparisons were conducted using the Wilcoxon signed-rank test. Agreement between residents and attendings was calculated using a linear-weighted Gwet's AC2. A secondary analysis investigated resident perception of autonomy stratified by attending perception of competency using Kruskal-Wallis tests. Results:. One hundred forty-two surveys were completed over one academic year. Residents reported a 4-point higher median O-SCORE (34) than attendings (30; p < 0.01; agreement = 0.63). Residents perceived less opportunity compared with attendings, with a median opportunity to complete each step of 54% vs. 70% (p < 0.01; agreement = 0.39). Residents also perceived lower percent completed of the key steps compared with attendings, with medians of 52% vs. 61% (p < 0.01; agreement = 0.37). Resident perceived opportunity increased with higher attending reported O-SCOREs (p < 0.01) and percent completion of the key steps (p < 0.01). No statistically significant increase in perceived opportunity was observed the with post-graduate year (PGY) level (p = 0.35). Discussion:. This study demonstrated a significant difference in perception between residents and attendings regarding resident competency and autonomy during arthroscopic rotator cuff repairs. It also demonstrated that with increasing attending perception of competency, there was an increasing resident perception of autonomy, but there was no statistically significant difference of perceived autonomy based on the PGY-level.

Abstract. Objectives:. To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial. Design:. Pilot trial. Setting:. Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. Patients/Participants:. Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation. Intervention:. Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. Main Outcome Measurements:. Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence). Results:. Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months. Conclusions:. Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.

Abstract Background Surgically-managed fractures, particularly open fractures, are associated with high rates of surgical site infections (SSIs). To reduce the risk of an SSI, orthopaedic surgeons routinely clean open fracture wounds in the emergency department (ED) and then apply a bandage to the open wound. Prior to the surgical incision, it is standard practice to prepare the fracture region with an antiseptic skin solution as an additional SSI prevention strategy. Multiple antiseptic solutions are available. Objectives To explore the variation in practice patterns among orthopaedic surgeons regarding antiseptic solution use in the ED and antiseptic preparatory techniques for fracture surgery. Methods We developed a 27-item survey and surveyed members of several orthopaedic associations. Results Two hundred and-ten surveys were completed. 71.0% of respondents irrigate the open wound and skin in the ED, primarily with saline alone (59.7%) or iodine-based solutions (32.9%). 90.5% of responders indicated that they dress the open wound in the ED, with 41.0% applying a saline-soaked bandage and 33.7% applying an iodine-soaked dressing (33.7%). In their surgical preparation of open fractures, 41.0% of respondents used an iodine-based solution, 26.7% used a chlorhexidine gluconate (CHG)-based solution, and 31.4% used a combination of the two. In closed fractures, 43.8% of respondents used a CHG-based solution, 28.1% used an iodine-based solution, and 27.1% used a combination. Despite theoretical concerns about the use of alcohol in open wounds, 51.4% used alcohol-based solutions or alcohol alone during skin preparation of open fractures. Conclusions A lack of consensus exists regarding use of antiseptic surgical preparation solutions for fractures. High-quality clinical research is needed to assess the effectiveness of different surgical antiseptic preparation solutions on patient outcomes in fracture populations.

Abstract Background The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. Methods The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. Results The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75–3.04; RR: 1.39, 95% CI: 0.60–3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81–1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50–1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04–1.57). Conclusions Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. Trial registration NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

An amendment to this paper has been published and can be accessed via the original article.

Abstract. Introduction:. Prescription opioid use and misuse has accelerated rapidly in the United States over the past 2 decades. Orthopaedic surgeons are the third highest prescribers of opioids, and thus are contributing to this problem at a significant rate. Despite a surge in the number of publications on this issue, there has been little emphasis in the literature on disentangling the various factors contributing to opioid use and misuse among fracture patients. The goal of this study was to describe areas of focus and identify knowledge gaps present in the current literature on this important issue. Methods:. We employed a scoping review technique due to its ability to successfully address a broad research question. In order to better understand the type of information deemed relevant by opioid researchers, we further analyzed our search results by sorting the publications into the following categories: consumer-focused, provider-focused, focus on substitutes, industry-focused, and focus on regulations (at the institution, profession, and government level). Results:. The search strategies generated 8760 citations; of these, 1166 publications satisfied our inclusion criteria. Around 607 of these final abstracts were marked as “extremely relevant” (52%) and the other 559 (48%) were marked “relevant.” About 36.4% of the total included articles applied to the providers and 19.6% provided information on the consumer. A total of 25.2% of the included papers concerned substitutes for opioids, 15.7% focused on regulatory power in the opioid industry, and 14% considered opioids as an industry, including power of both current stakeholders and potential new entrants. Discussion:. The present study provides a thorough summary of existing literature on opioid use and misuse relevant to musculoskeletal trauma patients. Furthermore, the categorical division of the literature provides a unique perspective into the drivers contributing to the opioid epidemic, and may assist in development of effective interventions to reduce excessive opioid use following traumatic injuries. Our review allowed us to identify important aspects of the opioid industry and various drivers of abuse that were absent from the literature including involvement of the pharmaceutical industry on the opioid epidemic, the involvement of insurance companies in opioid distribution, and the use of nonopioid alternative medications such as nonsteroidal anti-inflammatory drugs (NSAIDs).

Background: The lifetime prevalence of intimate partner violence (IPV) for women presenting to health care settings is estimated to be 38–59%. With the goal of providing help to victims of abuse, numerous IPV assistance programmes have been developed and evaluated across multiple health care settings. Objective: Our scoping review provides an overview of this literature to identify key areas for potential evidence-based recommendations and to focus research priorities. Methods: We conducted a search of MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and psycINFO. We used broad eligibility criteria to identify studies that evaluated the effectiveness of IPV assistance programmes delivered within health care settings. We completed all screening and data extraction independently and in duplicate. We used descriptive statistics to summarize all data. Results: Forty-three studies met all eligibility criteria and were included in our scoping review. Nine categories of assistance programmes were identified: counselling/advocacy, safety assessment/planning, referral, providing IPV resources, home visitation, case management, videos, provider cueing, and system changes. Characteristics of programmes amongst studies frequently reporting positive results included those in which one type of active assistance was used (77.8% of studies reported positive results), a counsellor, community worker, or case manager provided the intervention (83.3% of studies reported positive results), and programmes that were delivered over more than five sessions (100.0% of studies reported positive results). Conclusions: IPV assistance programmes are heterogeneous with regards to the types of assistance they include and how they are delivered and evaluated. This heterogeneity creates challenges in identifying which IPV assistance programmes, and which aspects of these programmes, are effective. However, it appears that many different types of IPV assistance programmes can have positive impacts on women.