Search

Background: Osteochondral allograft transplantation (OCAT) and meniscus allograft transplantation (MAT) have each become more commonly implemented for the treatment of young to middle-aged patients with complex knee pathology. Evidence regarding tibiofemoral OCAT in the setting of concurrent MAT is limited. Hypothesis/Purpose: The purpose of this study was to characterize outcomes for femoral condyle OCAT with concurrent MAT (OCAT+MAT) in the ipsilateral compartment of patients after evidence-based shifts in practice. It was hypothesized that OCAT+MAT would be associated with successful outcomes characterized by statistically significant and clinically meaningful improvements in patient-reported outcome measures (PROMs) of knee pain and function in >80% of patients for at least 2 years after transplantation. Study Design: Case series; Level of evidence, 4. Methods: With institutional review board approval and documented informed consent, patients who underwent primary OCAT+MAT between 2016 and 2020 and enrolled in a lifelong registry for prospective collection of outcomes after OCAT were included. Patients with minimum 2-year follow-up data regarding complications, failures, adherence, and PROMs were analyzed. Patients who required OCAT and/or MAT revision or conversion to arthroplasty were defined as experiencing treatment failures. Results: A total of 23 consecutive patients (mean age, 37.1 years; mean body mass index, 28 kg/m2; 14 men) met the inclusion criteria, with a mean follow-up of 51 months (range, 24-86 months). The initial treatment success rate was 78% based on 5 initial treatment failures, and the overall success rate was 83% based on a successful revision OCAT. All failures occurred in the medial compartment. Older patient age (42.2 vs 32.1 years; P =.046) and nonadherence to postoperative restriction and rehabilitation protocols (P =.033; odds ratio, 14) were significant risk factors for treatment failure. All measured PROMs achieved significant improvements (P <.001) and minimum clinically important differences at a minimum of 2 years postoperatively. Conclusion: OCAT+MAT was associated with successful short- to mid-term outcomes in 83% of cases. Evidence-based shifts in practice were implemented before the enrollment of this patient cohort. Older patients and those who were not adherent to postoperative restriction and rehabilitation protocols had a significantly higher risk for treatment failure and subsequent conversion to arthroplasty. [ABSTRACT FROM AUTHOR]

Study Design: Retrospective cohort. Objective: To compare the rates of all-cause surgical complications of synthetic interbody devices versus allograft or autograft in patients undergoing 1-2 levels anterior cervical discectomy and fusion (ACDF) procedures. Summary of Background Data: Cervical degenerative disorders affect up to 60% of older adults in the United States. Both traditional allograft or autograft and synthetic interbody devices (polyetheretherketone or titanium) are used for decompression and arthrodesis, with increasing utilization of the latter. However, the differences in their postsurgical complication profiles are not wellcharacterized. Patients and Methods: Patients who underwent 1-2 level ACDFs for cervical radiculopathy or myelopathy between 2010 and 2022 were identified using the PearlDiver Mariner all-claims insurance database. Patients undergoing surgery for nondegenerative pathologies, such as tumors, trauma, or infection, were excluded. 1:1 exact matching was performed based on factors that were significant predictors of all-cause surgical complications in a linear regression model. The primary outcome measure was the development of all-cause surgical complications after 1-2 level ACDFs. The secondary outcome was all-cause medical complications. Results: 1:1 exact matching resulted in two equal groups of 11,430 patients who received treatment with synthetic interbody devices or allograft/autograft. No statistically significant difference in all-cause surgical complications was found between the synthetic cohort and the allograft or autograft cohort after 1-2 level ACDFs (Relative Risk: 0.86, 95% confidence interval: 0.730–1.014, P = 0.079). No significant differences were observed regarding any specific surgical complications except for pseudoarthrosis (Relative Risk: 0.73, 95% confidence interval: 0.554–0.974, P = 0.037), which was higher in the allograft/autograft cohort. Conclusion: After 1:1 exact matching to control for confounding variables, the findings of this study suggest that all-cause surgical complications are similar in patients undergoing ACDFs with synthetic interbody devices or allograft/autographs. However, the rate of pseudarthrosis appears to be higher in patients with allograft/autographs. Future prospective studies are needed to corroborate these findings. [ABSTRACT FROM AUTHOR]

Background: Periprosthetic femoral fractures are a serious complication that put a high burden on patients. However, comprehensive analyses of their incidence, mortality, and complication rates based on large-registry data are scarce. Questions/purposes: In this large-database study, we asked: (1) What is the incidence of periprosthetic femoral fractures in patients 65 years and older in the United States? (2) What are the rates of mortality, infection, and nonunion, and what factors are associated with these outcomes? Methods: In this retrospective, comparative, large-database study, periprosthetic femoral fractures occurring between January 1, 2010, and December 31, 2019, were identified from Medicare physician service records encompassing services rendered in medical offices, clinics, hospitals, emergency departments, skilled nursing facilities, and other healthcare institutions from approximately 2.5 million enrollees. These were grouped into proximal, distal, and shaft fractures after TKA and THA. We calculated the incidence of periprosthetic femur fractures by year. Incidence rate ratios (IRR) were calculated by dividing the incidence in 2019 by the incidence in 2010. The Kaplan-Meier method with Fine and Gray subdistribution adaptation was used to calculate the cumulative incidence rates of mortality, infection, and nonunion. Semiparametric Cox regression was applied with 23 measures as covariates to determine factors associated with these outcomes. Results: From 2010 to 2019, the incidence of periprosthetic femoral fractures increased steeply (TKA for distal fractures: IRR 3.3 [95% CI 1 to 9]; p = 0.02; THA for proximal fractures: IRR 2.3 [95% CI 1 to 4]; p = 0.01). One-year mortality rates were 23% (95% CI 18% to 28%) for distal fractures treated with THA, 21% (95% CI 19% to 24%) for proximal fractures treated with THA, 22% (95% CI 19% to 26%) for shaft fractures treated with THA, 21% (95% CI 18% to 25%) for distal fractures treated with TKA, 22% (95% CI 17% to 28%) for proximal fractures treated with TKA, and 24% (95% CI 19% to 29%) for shaft fractures treated with TKA. The 5-year mortality rate was 63% (95% CI 54% to 70%) for distal fractures treated with THA, 57% (95% CI 54% to 62%) for proximal fractures treated with THA, 58% (95% CI 52% to 63%) for shaft fractures treated with THA, 57% (95% CI 52% to 62%) for distal fractures treated with TKA, 57% (95% CI 49% to 65%) for proximal fractures treated with TKA, and 57% (95% CI 49% to 64%) for shaft fractures treated with TKA. Age older than 75 years, male sex, chronic obstructive pulmonary disease (HR 1.48 [95% CI 1.32 to 1.67] after THA and HR 1.45 [95% CI 1.20 to 1.74] after TKA), cerebrovascular disease after THA, chronic kidney disease (HR 1.28 [95% CI 1.12 to 1.46] after THA and HR 1.50 [95% CI 1.24 to 1.82] after TKA), diabetes mellitus, morbid obesity, osteoporosis, and rheumatoid arthritis were clinical risk factors for an increased risk of mortality. Within the first 2 years, fracture-related infections occurred in 5% (95% CI 4% to 7%) of patients who had distal fractures treated with THA, 5% [95% CI 5% to 6%]) of patients who had proximal fractures treated with THA, 6% (95% CI 5% to 7%) of patients who had shaft fractures treated with THA, 6% (95% CI 5% to 7%) of patients who had distal fractures treated with TKA, 7% (95% CI 5% to 9%) of patients who had proximal fractures treated with TKA, and 6% (95% CI 4% to 8%) of patients who had shaft fractures treated with TKA. Nonunion or malunion occurred in 3% (95% CI 2% to 4%) of patients with distal fractures treated with THA, 1% (95% CI 1% to 2%) of patients who had proximal fractures treated with THA, 2% (95% CI 1% to 3%) of patients who had shaft fractures treated with THA, 4% (95% CI 3% to 5%) of those who had distal fractures treated with TKA,, 2% (95% CI 1% to 4%) of those who had proximal fractures treated with TKA, and 3% (95% CI 2% to 4%) of those who had shaft fractures treated with TKA. Conclusion: An increasing number of periprosthetic fractures were observed during the investigated period. At 1 and 5 years after periprosthetic femur fracture, there was a substantial death rate in patients with Medicare. Conditions including cerebrovascular illness, chronic kidney disease, diabetes mellitus, morbid obesity, osteoporosis, and rheumatoid arthritis are among the risk factors for increased mortality. After the surgical care of periprosthetic femur fractures, the rates of fracture-related infection and nonunion were high, resulting in a serious risk to affected patients. Patient well-being can be enhanced by an interdisciplinary team in geriatric traumatology and should be improved to lower the risk of postoperative death. Additionally, it is important to ensure that surgical measures to prevent fracture-related infections are followed diligently. Furthermore, there is a need to continue improving implants and surgical techniques to avoid often-fatal complications such as fracture-associated infections and nonunion, which should be addressed in further studies. Level of Evidence: Level III, therapeutic study. [ABSTRACT FROM AUTHOR]

Objective: To examine the frequency of autologous and alloplastic ear reconstructions for patients with microtia in the United States, and describe post-index procedure rates associated with each method. Design: Retrospective cohort study. Setting: Claims data from 500 + hospitals from IBM® MarketScan® Commercial and Multi-State Medicaid databases. Patients/Participants: A total of 649 patients aged 1 to 17 years with International Classification of Diseases, ninth/tenth revision (ICD-9/10) diagnoses for microtia, congenital absence of the ear, or hemifacial microsomia. Interventions: Alloplastic or autologous ear reconstruction between 2006 and 2018. Main Outcome Measure: Post-index procedures performed within 1 year following the index repair, analyzed across the study period and separately for each half of the study period (2006-2012, 2012-2018). Results: A total of 486 (75%) qualifying patients received autologous and 163 (25%) received alloplastic reconstruction. Secondary procedure rates were significantly higher in the autologous group at 90 days (P =.034), 180 days (P <.001), and at 365 days (P <.001). Alloplastic reconstruction accounted for 23.2% of reconstructions in the first half of the study period compared with 26.7% in the second half (P =.319). One-year secondary procedure rates in the autologous group were not significantly different between both halves of the study period (69.7% vs 67.1%, P =.558), but were significantly lower in the second half for the alloplastic group (44.9% vs 20.2%, P =.001). Conclusions: In these databases, autologous reconstruction is more common than alloplastic reconstruction. Autologous reconstruction is staged, with most undergoing a secondary procedure between 3 months and 1 year postoperatively. Secondary procedure rates decreased over time in patients undergoing alloplastic reconstruction. [ABSTRACT FROM AUTHOR]

Objectives: Injury to hyaline cartilage is problematic for both patients and physicians due to a limited potential for cartilage to heal. In the case of large chondral lesions, osteochondral allograft transplantation (OCA) is a popular and effective treatment modality with well-reported outcomes. However, given the costs of surgical operations in the United States, most patients require reimbursements through private insurance payers. It has previously been reported that the literature that substantiates the private commercial payers' policies regarding certain orthopaedic procedures is based on low level of evidence studies. However, to the best of our knowledge, this information is not available regarding policies on OCA. Therefore, the purpose of this study is to determine the level of evidence of the referenced cited in the policies regarding OCA for the leading commercial payers in the United States and to determine whether these references investigated the criteria that has been established by the payers. Methods: Ten national commercial private health insurance payers were identified. These payers included Centene Corporation, United Healthcare, Humana, Health Care Service Corporation, Cigna, Kaiser Permanente, WellCare Health Plans, The UPMC Health Plan, Anthem, and Aetna. Each payer was contacted either via phone or email to obtain their coverage policies regarding OCA. For each policy, all references related to OCA were collected for a standardized review completed by reviewers. The information collected included the criteria set by each policy, level of evidence of each reference, and whether the cited reference investigated the commercial payers' eligibility criteria for OCA. Results: Six main private health insurance companies had publicly available and current medical policies on osteochondral allograft transplants, including Centene Corporation, United Healthcare, Humana, Health Care Service Corporation, Cigna, and Aetna. A total of 110 references were found amongst these six medical healthcare providers of which 65 (59%) are primary journal articles, 29 (26%) are reviews or expert opinion articles, 5 (4.5%) are government reports, 6 (5.5%) are society guidelines, 3 (2.7%) are websites, 1 (1%) are rated as miscellaneous and 1 (1%) could not be found/accessed. Of the 102 references that were accessible, 1 reference showed a level of evidence (LOE) I (1%), 12 with LOE II (12%), 7 with LOE III (7%), 57 with LOE IV(57%), and 18 with LOE V(18%). The remaining 6 references had either a variable LOE or where an LOE rating was deemed unapplicable. Of the six main private health insurance medical policies attained, five (excluding United Healthcare) had corresponding publicly accessible medical necessity guidelines outlining criteria for procedural approval. From these five private health insurance companies, 22 of the 91 references directly tested for any of the listed medical necessity criteria. Amongst references directly testing the medical necessity criteria, 19 (86%) had a LOE IV, 1 (4.5%) with LOE I, 1 (4.5%) with LOE II, and 1 (4.5%) with a variable LOE. Conclusions: Analyzing commercial payers' policies highlights that the majority of cited references that substantiate these policies are of low level of evidence. Furthermore, less than a quarter (24.2%) of references directly investigate the policy's medical necessity. This perhaps illustrates a combination of a lack of high-quality studies investigating OCA and selective reporting of literature by these commercial payers. Patients and surgeons will benefit from future studies aimed at increasing awareness of the quality of evidence that helps establish commercial payers' policies. [ABSTRACT FROM AUTHOR]

During July 7-11, 2023, CDC received reports of two patients in different states with a tuberculosis (TB) diagnosis following spinal surgical procedures that used bone allografts containing live cells from the same deceased donor. An outbreak associated with a similar product manufactured by the same tissue establishment (i.e., manufacturer) occurred in 2021. Because of concern that these cases represented a second outbreak, CDC and the Food and Drug Administration worked with the tissue establishment to determine that this product was obtained from a donor different from the one implicated in the 2021 outbreak and learned that the bone allograft product was distributed to 13 health care facilities in seven states. Notifications to all seven states occurred on July 12. As of December 20, 2023, five of 36 surgical bone allograft recipients received laboratory-confirmed TB disease diagnoses; two patients died of TB. Whole-genome sequencing demonstrated close genetic relatedness between positive Mycobacterium tuberculosis cultures from surgical recipients and unused product. Although the bone product had tested negative by nucleic acid amplification testing before distribution, M. tuberculosis culture of unused product was not performed until after the outbreak was recognized. The public health response prevented up to 53 additional surgical procedures using allografts from that donor; additional measures to protect patients from tissue-transmitted M. tuberculosis are urgently needed. [ABSTRACT FROM AUTHOR]

Introduction: The incidence of osteonecrosis of the femoral head is estimated at about 10 to 20,000 patients annually, and, when left untreated, 80% or more of cases progress to femoral head collapse. A series of joint-preserving procedures have been developed to prevent/delay the need for hip arthroplasty. The aim of this study was to provide a five-year update: (1) evaluating temporal trends of arthroplasty vs. joint-preservation techniques such as core decompression, bone grafting, osteotomies, and arthroscopy; (2) determining proportions of procedures in patients aged less than vs. over 50 years; and (3) quantifying rates of specific operative techniques. Methods: A total of 10,334 patients diagnosed with osteonecrosis of the femoral head and having received hip surgery were identified from a nationwide database between 1 January 2010 and 31 December 2019, by using the International Classification of Disease, the Ninth/Tenth revision (ICD-9/10) codes. The percentage of patients managed by each operative procedure was calculated annually. To identify trends, patients were grouped by age under/over 50 years and divided into a joint-preserving and a non-joint-preserving (arthroplasty) group. Chi-squared tests were performed to compare the total number of procedures per year. Results: Rates of arthroplasty far exceeded those for joint-preserving procedures. However, from 2015 to 2019, significantly more joint-preserving procedures were performed than in 2010 to 2014 (4.3% vs. 3.0%, P < 0.001). Significantly more joint-preserving procedures were performed in patients aged < 50 years relative to those ≥ 50 years (7.56% vs. 1.86%, P < 0.001). Overall, total hip arthroplasty was the most common procedure (9,814; 94.97%) relative to core decompression (331; 3.20%), hemiarthroplasty/resurfacing (102; 0.99%), bone grafting (48; 0.46%), and osteotomy (5; 0.05%). Conclusion: Management of patients who have osteonecrosis of the femoral head continues to be predominantly arthroplasty procedures, specifically, total hip arthroplasty. Our findings suggest a small, but significant trend toward increased joint-preserving procedures, especially in patients under 50 years. In particular, the proportion of patients receiving core decompression has increased significantly from 2015 to 2019 relative to prior years. [ABSTRACT FROM AUTHOR]

Objective : The aim of this study was to examine internal responsiveness and estimate minimally important differences (MIDs) for CLEFT-Q scales. Design : In this prospective cohort study, participants completed the CLEFT-Q appearance and health-related quality of life (HRQL) scales before and six months after cleft-related surgery. Setting : Seven cleft centres in Canada, USA and UK participated. Patients/Participants : Patients were ages 8–29 years with CL/P. Interventions : Patients underwent rhinoplasty, orthognathic or cleft lip scar revision surgery. Main Outcome Measure(s) : Internal responsiveness was examined using Cohen's d effect sizes (ESs) based on the following interpretation: 0.20–0.49 small, 0.50–0.79 moderate and ≥ 0.80 large. MIDs were estimated using two distribution-based approaches. Results : Participants had a rhinoplasty (n = 31), orthognathic (n = 21) or cleft lip scar revision (n = 18) surgery. Most participants were males (56%) and aged 8–11 years (41%). Following rhinoplasty, ESs were larger for the nose (0.92, p = 0.001) and nostrils (0.94, p < 0.001) scales than for the face scale (0.51, p = 0.003). MIDs ranged between 6.2–10.4. For orthognathic surgery, larger ES was observed for the jaws scale (1.80, p < 0.001) compared with the teeth (1.16, p < 0.001), face (1.15, p = 0.001) and lips (0.94, p < 0.001) scales. MIDs ranged between 5.9–14.4. In the cleft lip scar revision sample, the largest ES was observed for the nose scale (0.76, p = 0.03), followed by lips (0.58, p = 0.009) and cleft lip scar (0.50, p = 0.043) scales. MIDs ranged between 6.4–12.3. Conclusions : CLEFT-Q detected change in key outcomes for three cleft-specific surgeries, providing evidence of its responsiveness. Estimated MIDs will aid in interpreting this PROM. [ABSTRACT FROM AUTHOR]

Objective: CLEFT-Q is a condition-specific patient-reported outcome measure (PROM) for patients with cleft lip and/or palate (CL/P). The aim of this study was to examine the cross-sectional construct validity of the CLEFT-Q scales. Design: Construct validity was assessed through a prospective study that tested hypotheses regarding correlations of scores with other PROMs that measure related constructs. Setting: Seven cleft centres in Canada, the USA, and UK were involved. Patients/Participants: Patients were aged eight to 29 years with CL/P. Interventions: Before undergoing rhinoplasty, orthognathic, cleft lip scar revision, and alveolar bone graft, participants were asked to complete the following PROMs: CLEFT-Q (9 scales), Child Oral Health Impact Profile (socio-emotional subscale) and Cleft Hearing Appearance and Speech Questionnaire (features 1 subscale). Main Outcome Measure(s): The correlation coefficients examining the relationship between the scales were the main outcome measures. Correlations (Spearman) were calculated and interpreted as follows: <0.3 weak, 0.30 to 0.50 moderate, ≥0.50 strong. Results: Participants (n = 177) were mostly male (61%) and aged between eight and 11 years (42%). Overall, 38 of 52 (73%) hypotheses tested were supported. More specifically, 20 of 26 (77%) hypotheses about correlations between the appearance scales were supported, two of three (67%) hypotheses about correlations between the health-related quality of life scales were supported, and 16 of 23 (70%) hypotheses about correlations between the appearance and health-related quality of life scales were supported. Conclusions: Cross-sectional construct validity of the CLEFT-Q scales adds further evidence of the psychometric properties of this instrument. [ABSTRACT FROM AUTHOR]

To describe pre– and post–alveolar bone graft (ABG) practice protocols of orthodontists associated with American Cleft Palate-Craniofacial Association–approved cleft and cleft/craniofacial teams. Electronic survey responses from team orthodontists were evaluated regarding pre-ABG orthodontic treatment type(s), timing of post-ABG imaging and post-ABG orthodontic treatment, and craniofacial orthodontic fellowship training status of the team orthodontists. A P value of <.05 was considered significant. Of 31 responding orthodontists, 54.8% had fellowship training and 45.2% did not. Pre-ABG orthodontic preparation ranged from solely maxillary expansion for alveolar segment alignment (35.5%) to a combination of maxillary expansion for both alveolar segment alignment and posterior crossbite correction, anterior tooth alignment, and anterior crossbite correction (19.4%). Most captured post-ABG radiographs prior to orthodontic tooth movement (90.3%). Orthodontists began treatment at least 6 months (35.5%), 2–4 months (32.3%), or 4–6 months (29%) post-ABG. No significant differences were found when comparing fellowship subgroups. In addition, 47.1% of fellowship-trained orthodontists deferred post-ABG orthodontic treatment to at least 6 months post-operatively, vs 21.4% of non–fellowship trained orthodontists (P =.14). A large variation in approaches is evident in pre-ABG orthodontic treatment types and timing of post-ABG treatment. Post-operative imaging is pursued by most orthodontists to assess graft status prior to initiating orthodontic treatment. Additional clinical research is needed to support providers in their decision-making with regard to evidence-based approaches. [ABSTRACT FROM AUTHOR]

Objective : Secondary procedures optimize outcomes following cleft lip and palate (CL/P) repair. We analyzed the association between race and the utilization and timing of revisionary/secondary cleft surgeries in the United States. Design : Primary CL/P repair, revisions, and secondary procedures—cleft rhinoplasty, speech surgery, and alveolar bone grafting (ABG)—performed from 2014–2018 were identified from the Pediatric National Surgical Quality Improvement Program (NSQIP) database. Utilization estimates were derived via univariable and multivariable logistic regression. A Kruskal-Wallis rank-sum test and multivariable linear regression were used to assess differences in timing for each procedure cohort. Main Outcome Measures : The primary outcome measures were the odds of a patient being a certain race/ethnicity, and the age at which patients of different race/ethnicity receive surgery. Results : There were 23 780 procedures analyzed. After controlling for sex, diagnosis, and functional status, there were significant differences in utilization estimates across procedure groups. Primarily, utilization was lowest in patient who were Black for cleft rhinoplasty (OR = 0.70, P =.023), ABG (OR = 0.44, P <.001) and speech surgery (OR = 0.57, P =.012), and highest in patients who were Asian patients in all surgery cohorts (OR 2.05-4.43). Timing of surgery also varied by race, although differences were minimal. Conclusions: Estimates of utilization and timing of secondary cleft procedures varied by race, particularly among patients who were Black (poor utilization) or Asian (high utilization). Further studies should identify the causes and implications of underutilized and/or delayed cleft care. [ABSTRACT FROM AUTHOR]

Objective: To determine if secondary alveolar bone grafting (SABG) timing in patients with cleft lip and palate (CLP) influences the future need for additional maxillary advancement procedures, particularly Le Fort I osteotomy with rigid external distraction (RED). Design: Retrospective cohort study. Groups were separated by SABG timing: early mixed dentition (ages 68 years) or late mixed dentition (ages 9-11 years). The criterion for RED was negative overjet ≥8 mm, and sufficient dental development for RED. Setting: Single tertiary care institution. Patients: Patients with CLP that underwent SABG from 2010 to 2015. Exclusion criteria included syndromic conditions, SABG surgery at age >12 years, current age <12 years, and <2 years follow-up. 104 patients were included. Main outcome measures: The number of RED candidates and treated patients. Results: There was no statistical difference in the number of RED candidates (P =.0718) nor treated patients (P =.2716) based on SABG timing; stratification by laterality was also insignificant. Early SABG is associated with higher odds of being a RED candidate (pooled, unilateral, bilateral) and treated patient (pooled and unilateral); however, there were no statistically significant associations between SABG timing and the number of RED candidates and treated patients as determined by logistic regression models. Conclusion: There is no statistically significant association between SABG timing and the odds of being a RED candidate or treated patient. Future prospective studies are recommended to assess the relationship between SABG timing and maxillary growth in patients with CLP. [ABSTRACT FROM AUTHOR]

A nationwide tuberculosis outbreak linked to a viable bone allograft product contaminated with Mycobacterium tuberculosis was identified in June 2021. Our subsequent investigation identified 73 healthcare personnel with new latent tuberculosis infection following exposure to the contaminated product, product recipients, surgical instruments, or medical waste. [ABSTRACT FROM AUTHOR]

Background: The objectives of this study were to build upon previously-reported 12-month findings by retrospectively comparing 24-month follow-up hospitalization charges and potentially-relevant readmissions in US lumbar fusion surgeries that employed either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a nationwide healthcare system database. Methods: A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2 in the original study, of whom 3,792 patients (23.4%) were identified in the current study with all-cause readmissions during the 24-month follow-up period. Confounding baseline patient, procedure, and hospital characteristics found in the original study were used to adjust multivariate regression models comparing differences in 24-month follow-up hospitalization charges (in 2020 US dollars) and lengths of stay (LOS; in days) between the groups. Differences in potentially-relevant follow-up readmissions were also compared, and all analyses were repeated in the subset of patients who only received treatment at a single level of the spine. Results: The adjusted cumulative mean 24-month follow-up hospitalization charges in the full cohort were significantly lower in the V-CBA group ($99,087) versus the rhBMP-2 group ($124,389; P < 0.0001), and this pattern remained in the single-level cohort (V-CBA = $104,906 vs rhBMP-2 = $125,311; P = 0.0006). There were no differences between groups in adjusted cumulative mean LOS in either cohort. Differences in the rates of follow-up readmissions aligned with baseline comorbidities originally reported for the initial procedure. Subsequent lumbar fusion rates were significantly lower for V-CBA patients in the full cohort (10.12% vs 12.00%; P = 0.0002) and similar between groups in the single-level cohort, in spite of V-CBA patients having significantly higher rates of baseline comorbidities that could negatively impact clinical outcomes, including bony fusion. Conclusions: The results of this study suggest that use of V-CBA for lumbar fusion surgeries performed in the US is associated with substantially lower 24-month follow-up hospitalization charges versus rhBMP-2, with both exhibiting similar rates of subsequent lumbar fusion procedures and potentially-relevant readmissions. [ABSTRACT FROM AUTHOR]

Purpose: This retrospective study evaluated the use of a composite graft of recombinant human bone morphogenetic protein-2 (rhBMP-2) and particulate mineralized bone allograft protected by a titanium mesh for vertical bone augmentation. Materials and Methods: A review of data on patients from four oral and maxillofacial surgery practices in the United States who required vertical augmentation prior to implant treatment was conducted. Vertical augmentation was accomplished with rhBMP-2 in an absorbable collagen sponge (ACS) carrier and particulate allograft. Cone beam computed tomography was used to measure vertical bone gains using this technique. Results: Sixteen vertical ridge augmentation procedures were performed in 15 patients. The maximum vertical bone gains ranged from 4.4 to 16.3 mm. The average maximum vertical bone gain was 8.53 mm. The procedure allowed implant placement in all patients. Forty implants were inserted into the grafted ridges after a minimum of 6 months of healing. All implants integrated and were used for prosthetic support. Conclusion: This study suggests that rhBMP-2/ACS and particulate mineralized bone allograft protected by a titanium mesh offers favorable vertical bone gains to allow dental implant placement. [ABSTRACT FROM AUTHOR]

Background: Orthodontic treatment can greatly impact the periodontium, especially in dentitions with a thin periodontal phenotype. Orthodontic tooth movement can result into iatrogenic sequelae to these vulnerable anatomic conditions, such as development and exacerbation of bony dehiscence or fenestration defects, which can manifest loss of periodontal support and gingival recession (GR). This systematic review aimed to investigate whether periodontal phenotype modification therapy (PhMT) involving hard tissue augmentation (PhMT-b) or soft tissue augmentation (PhMT-s) has clinical benefits for patients undergoing orthodontic treatment.Methods: An electronic search was performed in two major databases for journals published in English language from January 1975 to January 2019 and a hand search of printed journals was also performed to identify human clinical trials reporting clinical and radiographic outcomes of patients receiving orthodontic treatment with or without hard and soft tissue augmentation procedures. Data were extracted and organized into tables for qualitative assessment.Results: Eight studies were identified evaluating the outcomes of PhMT in patients undergoing orthodontic therapy. Six studies evaluated patients receiving PhMT-b via corticotomy-assisted orthodontic therapy (CAOT) and simultaneous bone augmentation while the other two received PhMT-s before tooth movement. No studies investigated PhMT-b alone without CAOT and most studies focused on the mandibular anterior decompensation movements. There was high heterogeneity in the study design and inconsistency of the reported outcomes; therefore, a meta-analysis was not performed. Evidence at this moment supports CAOT with hard tissue augmentation accelerated tooth movement. However, only two studies provided direct comparison to support that CAOT with PhMT-b reduced the overall treatment time compared with conventional orthodontic treatment. No periodontal complications or evidence of severe root resorption were reported for both groups. Four studies provided radiographic assessment of the PhMT-b and demonstrated increased radiographic density or thicker facial bone after the treatment. Two studies reported an expanded tooth movement. One study reported an increase in keratinized tissue width post-CAOT plus PhMT-b, while another study with a 10-year follow-up showed a lower degree of relapse using the mandibular irregularity index when compared with conventional tooth movement alone. Two studies examined the effect of PhMT-s before orthodontic treatment. Unfortunately, no conclusions can be drawn because of the limited number of studies with contradicting outcomes.Conclusions: Within the limited studies included in this systematic review, PhMT-b via particulate bone grafting together with CAOT may provide clinical benefits such as modifying periodontal phenotype, maintaining or enhancing facial bone thickness, accelerating tooth movement, expanding the scope of safe tooth movement for patients undergoing orthodontic tooth movement. The benefits of PhMT-s alone for orthodontic treatment remain undetermined due to limited studies available. However, PhMT-b appears promising and with many potential benefits for patients undergoing orthodontic tooth movement. There is a need for a higher quality of randomized controlled trials or case control studies with longer follow-up to investigate the effects of different grafting materials and surgical sites other than mandibular anterior region. [ABSTRACT FROM AUTHOR]

Background: Recent studies demonstrated a 5% increase in cartilage repair procedures annually in the United States. There is currently no consensus regarding a superior technique, nor has there been a comprehensive evaluation of postoperative clinical outcomes with respect to a minimal clinically important difference (MCID). Purpose: To determine the proportion of available cartilage repair studies that meet or exceed MCID values for clinical outcomes improvement over short-, mid-, and long-term follow-up. Study Design: Systematic review and meta-analysis. Methods: A systematic review was performed via the Medline, Scopus, and Cochrane Library databases. Available studies were included that investigated clinical outcomes for microfracture (MFX), osteoarticular transfer system (OATS), osteochondral allograft transplantation, and autologous chondrocyte implantation/matrix-induced autologous chondrocyte implantation (ACI/MACI) for the treatment of symptomatic knee chondral defects. Cohorts were combined on the basis of surgical intervention by performing a meta-analysis that utilized inverse-variance weighting in a DerSimonian-Laird random effects model. Weighted mean improvements in International Knee Documentation Committee (IKDC), Lysholm, and visual analog scale for pain (VAS pain) scores were calculated from preoperative to short- (1-4 years), mid- (5-9 years), and long-term (≥10 years) postoperative follow-up. Mean values were compared with established MCID values per 2-tailed 1-sample Student t tests. Results: A total of 89 studies with 3894 unique patients were analyzed after full-text review. MFX met MCID values for all outcome scores at short- and midterm follow-up with the exception of VAS pain in the midterm. OATS met MCID values for all outcome scores at all available time points; however, long-term data were not available for VAS pain. Osteochondral allograft transplantation met MCID values for IKDC at short- and midterm follow-up and for Lysholm at short-term follow-up, although data were not available for other time points or for VAS pain. ACI/MACI met MCID values for all outcome scores (IKDC, Lysholm, and VAS pain) at all time points. Conclusion: In the age of informed consent, it is important to critically evaluate the clinical outcomes and durability of cartilage surgery with respect to well-established standards of clinical improvement. MFX failed to maintain VAS pain improvements above MCID thresholds with follow-up from 5 to 9 years. All cartilage repair procedures met MCID values at short- and midterm follow-up for IKDC and Lysholm scores; ACI/MACI and OATS additionally met MCID values in the long term, demonstrating extended maintenance of clinical benefits for patients undergoing these surgical interventions as compared with MFX. [ABSTRACT FROM AUTHOR]

Study Design: Systematic review OBJECTIVE.: To undertake a systematic review of published literature to evaluate efficacy of bone graft substitutes on radiographic and clinical outcomes in single- or double-level anterior cervical discectomy and fusion (ACDF) for degenerative disease.Summary Of Background Data: ACDF is one of the most common spinal surgeries completed in the United States. Today bone graft substitutes including ceramic-based synthetic bone grafts, allografts, bone morphogenetic proteins (BMPs), mesenchymal stem cells, and bone marrow aspirate are widely used to enhance fusions; even though the efficacy of these substitutes is poorly defined. Critical evaluation of these products is necessary to optimize radiographic and clinical outcomes for ACDF in degenerative disease.Methods: A systematic literature review of 22 published articles was conducted. All articles reported results on patients who underwent a single- or double-level ACDF performed using a bone graft substitute and reported results on radiographic fusion rates at least 6 months after surgery.Results: All studies using BMP showed 100% fusion rate despite length of the study or whether additional bone graft substitutes were used. Use of only ceramic-based synthetics had the lowest fusion rate, 80.5%. Use of only mesenchymal stem cells resulted in an average fusion rate of 87.7%. When used alone, allograft resulted in an average fusion rate of 87.3%. This was significantly influenced by one outlier, Kim et al, which when removed, increased the fusion rate to 93.5%. Clinical outcomes were improved postoperatively irrespective of the graft used, although dysphagia was significantly greater in studies using BMP (P < 0.001).Conclusion: Allograft alone has the lowest cost with similar fusion rates and clinical outcomes compared to other bone graft substitutes. Physicians should consider this when choosing to use bone graft substitutes for routine ACDFs.Level Of Evidence: 4. [ABSTRACT FROM AUTHOR]

Background: During the conflicts in Iraq and Afghanistan, more than 52,000 U.S. military members were wounded in action. The battlefield mortality rate was lower than in past conflicts, however, those surviving often had complex soft tissue and bone injuries requiring multiple surgeries. This report describes the rates, types, and risks of infections complicating the care of combat casualties.Patients and Methods: Infection and microbiology data obtained from the Trauma Infectious Disease Outcomes Study (TIDOS), a prospective observational study of infections complicating deployment-related injuries, were used to determine the proportion of infection, types, and associated organisms. Injury and surgical information were collected from the Department of Defense Trauma Registry. Multivariable Cox proportional hazards and logistic regression models were used to evaluate potential factors associated with infection.Results: From 2009-2012, 1,807 combat casualties were evacuated to U.S. TIDOS-participating hospitals. Among the 1,807 patients, the proportion of overall infections from time of injury through initial U.S. hospitalization was 34% with half being skin, soft tissue, or bone infections. Infected wounds most commonly grew Enterococcus faecium, Pseudomonas aeruginosa, Acinetobacter spp. or Escherichia coli. In the multivariable model, amputation, blood transfusions, intensive care unit admission, injury severity scores, mechanical ventilation, and mechanism of injury were associated with risk of infection.Conclusions: One-third of combat casualties from Iraq and Afghanistan develop infections during their initial hospitalization. Amputations, blood transfusions, and overall injury severity are associated with risk of infection, whereas more easily modifiable factors such as early operative intervention or antibiotic administration are not. [ABSTRACT FROM AUTHOR]

Context: Given its young, predominately male demographics and intense physical demands, the US military remains an ideal cohort for the study of anterior shoulder instability.Evidence Acquisition: A literature search of PubMed, MEDLINE, and the Cochrane Database was performed to identify all peer-reviewed publications from 1950 to 2016 from US military orthopaedic surgeons focusing on the management of anterior shoulder instability.Study Design: Clinical review.Level Of Evidence: Level 4.Results: The incidence of anterior shoulder instability events in the military occurs at an order of magnitude greater than in civilian populations, with rates as high as 3% per year among high-risk groups. With more than 90% risk of a Bankart lesion and high risk for instability recurrence, the military has advocated for early intervention of first-time shoulder instability while documenting up to 76% relative risk reduction versus nonoperative treatment. Preoperative evaluation with advanced radiographic imaging should be used to evaluate for attritional bone loss or "off-track" engaging defects to guide comprehensive surgical management. With complex recurrent shoulder instability and/or cases of clinically significant osseous lesions, potential options such as remplissage, anterior open capsular procedures, or bone augmentation procedures may be preferentially considered.Conclusion: Careful risk stratification, clinical evaluation, and selective surgical management for at-risk military patients with anterior shoulder instability can optimize the recurrence risk and functional outcome in this population. [ABSTRACT FROM AUTHOR]

The article discusses two infectious diseases-related studies. One reports on a large and lethal tuberculosis outbreak in the U.S. linked to the implantation of infected bone graft product. Another study presents the case of a 14-year-old boy who presented with a draining sinus of his right proximal arm and was diagnosed with chronic osteolyelitis due to schistosomiasis.

With greater than 500,000 orthopaedic procedures performed in the United States each year requiring a bone graft, the development of novel graft materials is necessary. We report that some porous polymer/ceramic composite scaffolds possess intrinsic osteoinductivity as shown through their capacity to induce in vivo host osteoid mineralization and in vitro stem cell osteogenesis making them attractive synthetic bone graft substitutes. It was discovered that certain low crystallinity ceramics partially dissociate into simple signaling molecules (i.e., calcium and phosphate ions) that induce stem cells to endogenously produce their own osteoinductive proteins. Review of the literature has uncovered a variety of simple signaling molecules (i.e., gases, ions, and redox reagents) capable of inducing other desirable stem cell differentiation through endogenous growth factor production. Inductive simple signaling molecules, which we have termed inducerons, represent a paradigm shift in the field of regenerative engineering where they can be utilized in place of recombinant protein growth factors. [ABSTRACT FROM AUTHOR]

Background: Obesity has reached epidemic proportions in the United States. Recently, obesity, especially morbid obesity, has been linked to increased rates of dislocation after THA. The reasons are unclear. Soft tissue engagement caused by increased thigh girth has been proposed as a possible mechanism for decreased joint stability. Questions/Purposes: We asked (1) whether thigh soft tissue impingement could decrease THA stability, and if so, at what level of BMI this effect might become evident; and (2) how THA construct factors (eg, head size, neck offset, cup abduction) might affect stability in the morbidly obese. Methods: The obesity effect was explored by augmenting a physically validated finite element model of a total hip construct previously comprising just implant hardware and periarticular (capsular) soft tissue. The model augmentation involved using anatomic and anthropometric data to include graded levels of increased thigh girth. Parametric computations were run to assess joint stability for two head sizes (28 and 36 mm), for normal versus high neck offset, and for multiple cup abduction angles. Results: Thigh soft tissue impingement lowered the resistance to dislocation for BMIs of 40 or greater. Dislocation risk increased monotonically above this threshold as a function of cup abduction angle, independent of hardware impingement events. Increased head diameter did not substantially improve joint stability. High-offset necks decreased the dislocation risk. Conclusions: Excessive obesity creates conditions that compromise stability of THAs. Given such conditions, our model suggests reduced cup abduction, high neck offset, and full-cup coverage would reduce the risks of dislocation events. [ABSTRACT FROM AUTHOR]

Background: Novel bone substitutes have challenged the notion of autologous bone grafting as the 'gold standard' for the surgical treatment of fracture nonunions. The present study was designed to test the hypothesis that autologous bone grafting is equivalent to other bone grafting modalities in the management of fracture nonunions of the long bones. Methods: A retrospective review of patients with fracture nonunions included in two prospective databases was performed at two US level 1 trauma centers from January 1, 1998 (center 1) or January 1, 2004 (center 2), respectively, until December 31, 2010 (n = 574). Of these, 182 patients required adjunctive bone grafting and were stratified into the following cohorts: autograft (n = 105), allograft (n = 38), allograft and autograft combined (n = 16), and recombinant human bone morphogenetic protein-2 (rhBMP-2) with or without adjunctive bone grafting (n = 23). The primary outcome parameter was time to union. Secondary outcome parameters consisted of complication rates and the rate of revision procedures and revision bone grafting. Results: The autograft cohort had a statistically significant shorter time to union (198 ± 172-225 days) compared to allograft (416 ± 290-543 days) and exhibited a trend towards earlier union when compared to allograft/autograft combined (389 ± 159-619 days) or rhBMP-2 (217 ± 158-277 days). Furthermore, the autograft cohort had the lowest rate of surgical revisions (17%) and revision bone grafting (9%), compared to allograft (47% and 32%), allograft/autograft combined (25% and 31%), or rhBMP-2 (27% and 17%). The overall new-onset postoperative infection rate was significantly lower in the autograft group (12.4%), compared to the allograft cohort (26.3%) (P < 0.05). Conclusion: Autologous bone grafting appears to represent the bone grafting modality of choice with regard to safety and efficiency in the surgical management of long bone fracture nonunions. [ABSTRACT FROM AUTHOR]

The article offers information on the autogenous bone grafts or substitutes for dental implants in the U.S. It states that edentulous region recovery is one of the frequent challenges that dentists and implantodontists experienced. It mentions that the use of autogenous grafting of bones for bone reconstruction triggers numerous events. It notes that graft consolidation is vital to avoid loss of gingival volume because there is huge possibility that large portion of the important bones are replaced with the said process.

Abstract: Background context: Allograft bone is commonly used in various spinal surgeries. The large amount of recalled allograft tissue, particularly in recent years, has increased concerns regarding the safety of allograft bone for spinal surgery. An analysis of allograft recall and its safety in spinal surgery has not been reported previously. Purpose: To determine 1) the number and types of allograft recall and the reasons for recall, 2) the types of disease transmission to spine patients, and 3) assess the safety of allograft bone in spinal surgery. Study design/setting: Retrospective review. Methods: A retrospective review of all Food and Drug Administration (FDA) data from 1994 to June 2007 was reviewed to determine the amount and types of recalled allograft tissue. The literature and data from the Center for Disease Control were reviewed to determine the number and types of disease transmissions from allograft bone that have occurred to spine surgery patients during the study period. Results: There were 59,476 musculoskeletal allograft tissue specimens recalled by FDA during the study period, which accounts for 96.5% of all allograft tissue recalled in the United States. Improper donor evaluation, contamination, and recipient infections are the main reasons for allograft recall. There has been one case of human immunodeficiency virus infection transmission to a spine surgery patient in 1988. This is the only reported case of viral transmission. There are no reports of bacterial disease transmission from the use of allograft bone to spine surgery patients. Conclusions: The precise number of allografts used in spine surgery annually and the precise incidence of disease transmission to spine surgery patients linked to the use of allograft tissue is unknown. Musculoskeletal allograft tissue accounts for the majority of recalled tissue by FDA. Despite the large number of allograft recalls in this country, there is only one documented case in the literature of disease transmission to a spine surgery patient. There appears to be no overt risk associated with the use of allograft bone in spine surgery. However, as discussed in this article, there are certain aspects regarding the use of allograft bone that should be considered. [Copyright &y& Elsevier]

Abstract: The demand for bone grafts in orthopaedic and craniofacial surgery is steadily increasing. Estimations suggest that about 500,000 are performed annually in the United States that include bone grafting as a component of the surgery, and the majority of these surgeries employ autografts. This perspective focuses on the biological events that occur during osseointegration of such bone grafts. Here, three key factors of graft osseointegration – the embryonic origin, the inclusion of skeletal progenitor cells, and the integrity of the recipient site – are discussed. Altogether, they form the foundation for survival of the bone graft and eventually for a positive clinical outcome of the procedure. [Copyright &y& Elsevier]

Background: Utilization of vascularized bone grafts rigidly fixated with titanium reconstruction plates is the method of choice for reconstruction of segmental mandibular defects. We hypothesized that the use of the newer 2.0-mm locking reconstruction plate (LRP) is not associated with higher rates of complications when compared with larger, previously used plating systems. Methods: A retrospective case series of 184 patients undergoing 185 vascularized bone graft reconstruction procedures of the mandible was conducted. Results: There were 37 plate complications. There was no significant difference in complication rates for the 2 most used plate types (14.5% with the 2.0-mm LRP and 22.2% with the 2.4-mm LRP). Conclusions: Use of the smaller 2.0-mm LRP was not associated with an increase in the complications of plate fracture, exposure, infection, or nonunion. Because of its lower profile and ease of application, the 2.0-mm LRP is our plate of choice for mandibular reconstruction. © 2006 Wiley Periodicals, Inc. Head Neck, 2006 [ABSTRACT FROM AUTHOR]

Recombinant human bone morphogenetic protein-2 (rhBMP-2) has been tested for use in spinal fusion in several completed prospective, randomized clinical trials, beginning in 1997. After rhBMP-2 was demonstrated to be equivalent to autogenous iliac bone graft with regard to both fusion rate and clinical outcome, a scientific advisory panel convened by the U.S. Food and Drug Administration advised that rhBMP-2 be approved as the first complete bone-graft substitute for spinal fusion. Preclinical proof-of-concept, feasibility and efficacy studies laid the groundwork that established certain parameters for the clinical use of rhBMP-2. Each successive spinal fusion study contributed to the evolution of the design and dose of the carrier⁄protein combination.

The article discusses a study which examined the impact of T-cell depletion (TCD) of unrelented bone marrow (BM) grafts. The TCD randomized phase II and III multicenter trial at the National Heart, Lung and Blood Institute (NHLBI) in the U.S. compared the immune recovery in recipients of unmanipulated and TCD grafts from unrelated donors. The study found that αβTCD grafts revealed faster recovery from natural killers but lesser αβT-cells.

Background: The objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a large US healthcare system database. Potentially relevant re-admissions during the follow-up period were also assessed. Methods: A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3503 (21.66%) patients had follow-up re-admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially relevant re-admissions during the 12-month follow-up period. Results: The adjusted mean initial procedure and 12-month follow-up hospital charges were significantly lower in the V-CBA group versus the rhBMP-2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P < 0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V-CBA = $103,064, rhBMP-2 = $149,620; P < 0.0001). The adjusted mean initial LOS were significantly lower in the V-CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P < 0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12-month follow-up period (7.87 versus 7.46 days, respectively; P < 0.0001). Differences in rates of follow-up re-admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V-CBA patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes. Conclusions: The results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures. [ABSTRACT FROM AUTHOR]

Instrumented posterolateral lumbar fusion (PLF) surgery is commonly used to alleviate pain and other symptoms associated with degenerative conditions of the lumbosacral spine. Although autologous iliac crest bone graft (ICBG) remains the "gold standard" grafting material for these procedures, surgeons have sought alternatives to avoid the potential morbidity associated with ICBG harvest. OSTEOAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors. A prospective multicenter study was designed to enable comparison of this novel product to available data for autologous bone graft controls from large randomized controlled trials (RCTs). Compare 1-year outcomes from an ongoing study investigating radiographic and clinical outcomes to reported results for ICBG controls from a large RCT. Prospective multicenter single-arm study conducted in the United States. Consenting patients, 21 to 85 years of age, scheduled for PLF surgery with a diagnosis of degenerative disc disease (DDD), degenerative spondylolisthesis, and/or mild degenerative scoliosis. Bilateral radiographic fusion (blinded, multireader with adjudication) was assessed. Additional outcome measures included Oswestry Disability Index (ODI), Short Form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) scores, and improvement in leg/back pain scores. Product-related serious adverse events (SAEs) and secondary surgeries were also assessed. Forty-two patients were prospectively enrolled after obtaining IRB approval at each of 9 centers and underwent a 1-level (26 patients) or 2-level (16 patients) PLF procedure utilizing the novel BGS (67% BGS: 33% local bone graft). Clinical outcomes were measured and radiographic studies were obtained preop and postop at 1.5, 3, 6, and 12 months. Radiographic analysis included CT assessment of fusion at 12 months. One-year outcomes were available for 23 of the 26 patients who underwent a 1-level procedure and were compared to 1-year outcomes reported for ICBG controls from a large previously published RCT by estimation of novel BGS:ICBG Risk Ratios (RR) with 95% confidence intervals (CI). One-year fusion rates and results for each of the measures (novel BGS vs ICBG) are as follows: bilateral fusion = 73.9% (17/23) vs 82.5% (151/183) with RR 0.90 (0.69, 1.15 CI); ODI (>15 improvement) = 73.9% (17/23) vs 73.9% (150/203), RR 1.00 (0.77, 1.29 CI); leg pain = 95.7% (22/23) vs 87.6% (177/202), RR 1.09 (0.99, 1.21 CI); back pain = 91.3% (21/23) vs 93.1% (180/203), RR 0.98 (0.86, 1.12 CI); SF-36 MCS = 73.9% (17/23) vs 68.7% (138/201), RR 1.08 (0.83, 1.40); SF-36 PCS = 95.7% (22/23) vs 86.6% (174/201), RR 1.10 (1.00, 1.22 CI). No statistically significant difference was found in RR between groups for all comparisons. No product-related SAEs and only one secondary surgery were observed with the novel BGS. One-year clinical and radiographic outcomes following single-level PLF procedures with OSTEOAMP compare favorably to results reported for an ICBG control group from a large RCT. OSTEOAMP (Approved for this indication) [ABSTRACT FROM AUTHOR]

Lee K-I, Lee J-S, Jung H-H, Lee H-Y, Moon S-H, Kang K-T, Shim Y-B, Jang J-W. Inactivation of enveloped and non-enveloped viruses in the process of chemical treatment and gamma irradiation of bovine-derived grafting materials. Xenotransplantation 2012; 19: 365-369. © 2012 John Wiley & Sons A/S. Abstract Background: Xenografts, unlike other grafting products, cannot be commercialized unless they conform to stringent safety regulations. Particularly with bovine-derived materials, it is essential to remove viruses and inactivate infectious factors because of the possibility that raw materials are imbrued with infectious viruses. The removal of the characteristics of infectious viruses from the bovine bone grafting materials need to be proved and inactivation process should satisfy the management provision of the Food and Drug Administration (FDA). To date, while most virus inactivation studies were performed in human allograft tissues, there have been almost no studies on bovine bone. Methods: To evaluate the efficacy of virus inactivation after treatment of bovine bone with 70% ethanol, 4% sodium hydroxide, and gamma irradiation, we selected a variety of experimental model viruses that are known to be associated with bone pathogenesis, including bovine parvovirus (BPV), bovine herpes virus (BHV), bovine viral diarrhea virus (BVDV), and bovine parainfluenza-3 virus (BPIV-3). The cumulative virus log clearance factor or cumulative virus log reduction factor for the manufacturing process was obtained by calculating the sum of the individual virus log clearance factors or log reduction factors determined for individual process steps with different physicochemical methods. Results: The cumulative log clearance factors achieved by three different virus inactivation processes were as follows: BPV ≥17.73, BHV ≥20.53, BVDV ≥19.00, and BPIV-3 ≥16.27. On the other hand, the cumulative log reduction factors achieved were as follows: BPV ≥16.95, BHV ≥20.22, BVDV ≥19.27, and BPIV-3 ≥15.58. Conclusions: Treatment with 70% ethanol, 4% sodium hydroxide, or gamma irradiation was found to be very effective in virus inactivation, since all viruses were at undetectable levels during each process. We have no doubt that application of this established process to bovine bone graft manufacture will be effective and essential. [ABSTRACT FROM AUTHOR]

The article focuses on the growth of the global dental biomaterials market in 2007. It notes that global markets for dental biomaterials, which includes the U.S., Europe and Asia Pacific, and comprising dental bone graft substitutes, dental membranes and tissue regeneration materials, was valued in 2007 at about 300 million U.S. dollars. Also cited is the possible increase in the number of dental bone graft procedures due to the growing clinical awareness of the functional and aesthetic benefits of a dental implant.

The article reports on the decision of the Food and Drug Administration (FDA) to grant marketing approval to Medtronic Sofamor Danek Inc. for its InFuse Bone Graft in the U.S. The approval of FDA is based on the product's effectivity in dental use especially in filling space where bone is needed to place endosseous dental plants. The product also is recommended in making enough bone in the sinus area to place endosseous dental implants in the upper jaw.