A modified Delphi consensus statement on patellar instability: part I.

Aims: The aim of this study was to establish consensus statements on the diagnosis, nonoperative management, and indications, if any, for medial patellofemoral complex (MPFC) repair in patients with patellar instability, using the modified Delphi approach. Methods: A total of 60 surgeons from 11 countries were invited to develop consensus statements based on their expertise in this area. They were assigned to one of seven working groups defined by subtopics of interest within patellar instability. Consensus was defined as achieving between 80% and 89% agreement, strong consensus was defined as between 90% and 99% agreement, and 100% agreement was considered to be unanimous. Results: Of 27 questions and statements on patellar instability, three achieved unanimous consensus, 14 achieved strong consensus, five achieved consensus, and five did not achieve consensus. Conclusion: The statements that reached unanimous consensus were that an assessment of physeal status is critical for paediatric patients with patellar instability. There was also unanimous consensus on early mobilization and resistance training following nonoperative management once there is no apprehension. The statements that did not achieve consensus were on the importance of immobilization of the knee, the use of orthobiologics in nonoperative management, the indications for MPFC repair, and whether a vastus medialis oblique advancement should be performed.

A modified Delphi consensus statement on patellar instability: part II.

Aims: The aim of this study was to establish consensus statements on medial patellofemoral ligament (MPFL) reconstruction, anteromedialization tibial tubercle osteotomy, trochleoplasty, and rehabilitation and return to sporting activity in patients with patellar instability, using the modified Delphi process. Methods: This was the second part of a study dealing with these aspects of management in these patients. As in part I, a total of 60 surgeons from 11 countries contributed to the development of consensus statements based on their expertise in this area. They were assigned to one of seven working groups defined by subtopics of interest. Consensus was defined as achieving between 80% and 89% agreement, strong consensus was defined as between 90% and 99% agreement, and 100% agreement was considered unanimous. Results: Of 41 questions and statements on patellar instability, none achieved unanimous consensus, 19 achieved strong consensus, 15 achieved consensus, and seven did not achieve consensus. Conclusion: Most statements reached some degree of consensus, without any achieving unanimous consensus. There was no consensus on the use of anchors in MPFL reconstruction, and the order of fixation of the graft (patella first versus femur first). There was also no consensus on the indications for trochleoplasty or its effect on the viability of the cartilage after elevation of the osteochondral flap. There was also no consensus on postoperative immobilization or weightbearing, or whether paediatric patients should avoid an early return to sport.

An Initial Injection and a Crossover Injection of Amniotic Suspension Allograft Following Failed Treatment with Hyaluronic Acid or Saline Are Equally Effective in the Treatment of Moderate Symptomatic Knee Osteoarthritis Over 12 Months.

PURPOSE: The purpose of this crossover study was to determine the efficacy of amniotic suspension allograft (ASA) for moderate symptomatic knee osteoarthritis following failed treatment with hyaluronic acid (HA) or saline through 12 months' postcrossover injection using patient-reported and safety outcomes. METHODS: In this multicenter study, 95 patients from a 200-patient single-blind randomized controlled trial were eligible to crossover and receive a single injection of ASA 3 months after failed treatment with HA or saline. Patient-reported outcomes, including Knee Injury and Osteoarthritis Outcome Score (KOOS) and visual analog scale (VAS), were collected out to 12 months postcrossover to determine pain and function. Radiographs and blood were collected for assessment of changes. Statistical analyses were performed using mixed effects model for repeated measures. RESULTS: Treatment with ASA following failed treatment with HA or saline resulted in significant improvements in KOOS and VAS scores compared with crossover baseline. There were no differences in radiographic measures or anti-human leukocyte antigen serum levels compared with baseline and no severe adverse events reported. In addition, more than 55% of patients were responders at months 3, 6, and 12 as measured by the Outcome Measures in Arthritis Clinical Trials-Osteoarthritis Research Society International simplified responder criteria. There were no significant differences between the original ASA randomized group and crossover cohorts at any of the time points evaluated, suggesting that prior failed treatment with HA or saline did not significantly impact outcomes following treatment with ASA. CONCLUSIONS: This study showed that patients who previously failed treatment with HA or saline had statistically significant improvements in pain and function scores following a crossover injection of ASA that was sustained for 12 months, as measured by KOOS and VAS. There were no serious adverse events reported, and the injection was safe. LEVEL OF EVIDENCE: II, prospective cohort study.

The Large Focal Isolated Chondral Lesion.

Focal chondral defects (FCDs) of the knee can be a debilitating condition that can clinically translate into pain and dysfunction in young patients with high activity demands. Both the understanding of the etiology of FCDs and the surgical management of these chondral defects has exponentially grown in recent years. This is reflected by the number of surgical procedures performed for FCDs, which is now approximately 200,000 annually. This fact is also apparent in the wide variety of available surgical approaches to FCDs. Although simple arthroscopic debridement or microfracture are usually the first line of treatment for smaller lesions, chondral lesions that involve a larger area or depth require restorative procedures such as osteochondral allograft transplantation or other cell-based techniques. Given the prevalence of FCDs and the increased attention on treating these lesions, a comprehensive understanding of management from diagnosis to rehabilitation is imperative for the treating surgeon. This narrative review aims to describe current concepts in the treatment of large FCDs through providing an algorithmic approach to selecting interventions to address these lesions as well as the reported outcomes in the literature.

Regulatory and Ethical Aspects of Orthobiologic Therapies.

Orthobiologic therapies show significant promise to improve outcomes for patients with musculoskeletal pathology. There are considerable research efforts to develop strategies that seek to modulate the biological environment to promote tissue regeneration and healing and/or provide symptomatic relief. However, the regulatory pathways overseeing the clinical translation of these therapies are complex, with considerable worldwide variation. The introduction of novel biologic treatments into clinical practice raises several ethical dilemmas. In this review, we describe the process for seeking approval for biologic therapies in the United States, Europe, and Japan. We highlight a number of ethical issues raised by the clinical translation of these treatments, including the design of clinical trials, monitoring outcomes, biobanking, "off-label" use, engagement with the public, marketing of unproven therapies, and scientific integrity.

Variability in Private Payer Medical Policies for Osteochondral Allograft Transplantation Demonstrates the Absence of Standardization in Medical Criteria Between Payers.

Purpose: To define the criteria for coverage for a cartilage restoration procedure and osteochondral allograft (OCA) transplantation and to investigate coverage for OCA procedures among private payer medical policies. Methods: A systematic search of private payer websites was conducted to identify publicly available 2018 OCA medical policies. Medical criteria related to patient demographics, defect characteristics, and previous treatment were analyzed. Trends in coverage for treatment of talus and patella and the extent of restrictiveness of medical policies were evaluated from 2016 to 2018. The extent of restrictiveness of a policy was defined by number of medical criteria established by payer policies. Policies with >5, 3-5, and <3 specified criteria for OCAs were considered strongly, moderately, and weakly restrictive, respectively. Results: In total, 49 private payer medical policies for OCA transplantation were identified. Extracted criteria varied greatly between medical policies. Ten different defect size ranges were reported across payer policies. Criteria for patient body mass index was specified in 63% of policies. Criteria for failed arthroscopic or traditional surgical procedure were identified in 20% of the policies. More than one half of policies (51%) specified knee defect location to load-bearing surfaces. Analysis of trends in positive coverage statements and restrictiveness showed an increase from 4.7% in 2016 to 39.5% for talus, 4.7% to 7.0% for patella, and a slight shift (4.7% of payers) toward weakly restrictive medical policies. Conclusions: This study demonstrates wide variability and inconsistencies in published criteria among OCA medical policies. Clinical Relevance: This study informs clinicians of the current state of coverage for OCA transplantation, providing insights into the variability of payer policies and potential impact.

Inconsistent Reporting of Preauthorization Medical Criteria for Osteochondral Allograft Transplantation Surgery.

BACKGROUND: Although osteochondral allograft (OCA) transplantation has been a standard treatment for patients with osteochondral lesions, there is a disagreement in commercial payers' medical criteria regarding the definition of medical suitability and thus authorization for OCA transplantation. The primary goal of this study was to understand where consensus between a committee of experienced cartilage restoration surgeon scientists and payer policies existed and where there was significant disagreement. METHODS: U.S. private payers were identified by reviewing health insurance market research literature. Medical criteria were then obtained from publicly available payer medical polices. A literature review was conducted to identify supporting evidence for consensus statements based on private payer medical criteria. The MOCA (Metrics of Osteochondral Allograft) Committee, 30 experienced surgeons and subject-matter experts in OCA transplantation, used a Likert scale of 1 (strongly disagree) to 5 (strongly agree) to rank each statement. The extent of agreement and disagreement among participants was measured for each statement. Consensus was defined as agreement or disagreement of >75%. RESULTS: Fifty-seven statements regarding relevant medical criteria for OCA transplantation were included in the survey. All 30 MOCA Committee members completed the survey (100% response rate). Over half of the statements (52.6%) did not reach consensus. Of the remaining 27 statements that reached consensus, respondents agreed or strongly agreed with 16 statements, and disagreed or strongly disagreed with 11 statements. Inconsistent voting was observed for statements related to osteoarthritis, inflammation, and degenerative changes. CONCLUSIONS: Commercial payers are not consistent in the medical criteria used to define patient eligibility for authorization of OCA transplantation. In contrast, an expert panel of cartilage surgeons reached a consensus that OCA transplantation was clearly suitable for a variety of specific indications. This study demonstrates the need to standardize medical criteria for cartilage restoration based on the most current literature, as well as in conjunction with experienced cartilage restoration experts. LEVEL OF EVIDENCE: Therapeutic Level V . See Instructions for Authors for a complete description of levels of evidence.

Amniotic suspension allograft improves pain and function in a rat meniscal tear-induced osteoarthritis model.

BACKGROUND: Osteoarthritis is a degenerative disease of the knee that affects 250 million people worldwide. Due to the rising incidence of knee replacement and revision surgery, there is a need for a nonsurgical treatment to reduce pain and improve function in patients with knee osteoarthritis. Placental-derived allografts, such as an amniotic suspension allograft (ASA), provide growth factors and cytokines that could potentially modulate the inflammatory environment of osteoarthritis. The purpose of this study was to evaluate the efficacy of ASA in a rat medial meniscal tear (MMT) induced osteoarthritis model through histology, microCT, synovial fluid biomarkers, and behavioral testing. METHODS: Rats underwent MMT surgery at day - 7; at day 0, rats were injected with either ASA, vehicle control, or fibroblast growth factor-18 (FGF18). Behavioral testing, including gait analysis, pain threshold, incapacitance, and knee swelling were evaluated in-life, along with histology, microCT analysis of cartilage, and synovial fluid testing post-sacrifice. One MMT cohort was sacrificed at day 10, the other at day 21. A third cohort acted as a safety arm and did not receive MMT surgery; these rats were injected with either vehicle control or ASA and evaluated at day 3 and day 21. RESULTS: Behavioral testing showed a significant improvement in pain threshold, incapacitance, and gait following an injection of ASA. MicroCT showed significant improvements in cartilage thickness and attenuation at day 10 only, and histology showed no detrimental effects compared to the vehicle control at day 21. Synovial fluid analysis showed a significant increase in anti-inflammatory IL-10. The safety cohort showed no significant differences except for an increase in synovitis at day 21, which could be evidence of a xenogeneic response in this model. CONCLUSIONS: In this study, an injection of ASA was well tolerated with no adverse events. Improvements in pain and function, along with cartilage properties at day 10, were observed. Increases in anti-inflammatory cytokines was also seen, along with no significant cartilage degeneration at day 21 compared to the vehicle control. This study provides evidence for the use of ASA as a nonsurgical treatment for knee OA.

Evaluation of Commercially Available Knee Cartilage Restoration Techniques Stratified by FDA Approval Pathway.

BACKGROUND: Commercially available products used in knee cartilage reconstructive and restorative surgical practices fall under unique US Food and Drug Administration (FDA) regulatory pathways that determine the level of evidence required to market each product. PURPOSE: To evaluate the levels of evidence in the literature supporting commercially available cartilage repair procedures stratified by FDA regulatory pathway (section 351 vs section 361 of "Human Cells, Tissues, and Cellular and Tissue-Based Products" [HCT/P] in the Code of Federal Regulation) with the hypothesis that products requiring approval under a stringent regulatory pathway (351 HCT/P) have higher levels of evidence in the literature supporting use and that products with a less stringent regulatory pathway (361 HCT/P) have a higher number of products available for use in the United States. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: A search of the PubMed database was performed to identify all peer-reviewed articles pertaining to either allograft or autologous cartilage repair technologies. Predefined inclusion and exclusion criteria were used to find clinical, preclinical, and laboratory studies while excluding duplicates, systematic reviews, and products not available in the United States. Articles were categorized by regulatory pathway (351 and 361 HCT/P), and variables including publication year, type of publication, level of evidence, and number of publications were analyzed. RESULTS: After application of predefined criteria, 470 of 1924 articles were included in this study. The 351 HCT/P group was composed entirely of autologous chondrocyte implantation (ACI) technology; 94% of the 361 HCT/P group was composed of osteochondral allografts (OCA). The articles regarding 351 HCT/P were more likely to be clinical in nature than the articles on 361 HCT/P (80% vs 48%, respectively; P = .0001) and entailed significantly more level 1 studies (25 vs 0, respectively; P < .0001). Twice as many articles in the 351 HCT/P group were published in the American Journal of Sports Medicine compared with the 361 HCT/P group (71 vs 38, respectively; P = .18). CONCLUSION: Both ACI and OCA have robust evidence supporting their use, whereas the remaining regulated products have little or no supporting evidence. Technologies regulated by 351 HCT/P were more likely to be level 1 clinical studies and published in the highest impact journal. The 361 HCT/P pathway regulated many more products, with fewer articles supporting their use.

Treatment of post-meniscectomy knee symptoms with medial meniscus replacement results in greater pain reduction and functional improvement than non-surgical care.

PURPOSE: Partial meniscectomy is a common orthopedic procedure intended to improve knee pain and function in patients with irreparable meniscal tears. However, 6-25% of partial meniscectomy patients experience persistent knee pain after surgery. In this randomized controlled trial (RCT) involving subjects with knee pain following partial meniscectomy, it was hypothesized that treatment with a synthetic medial meniscus replacement (MMR) implant provides significantly greater improvements in knee pain and function compared to non-surgical care alone. METHODS: In this prospective, multicenter RCT, subjects with persistent knee pain following one or more previous partial meniscectomies were randomized to receive either MMR or non-surgical care. This analysis evaluated the 1-year outcomes of this 2-year clinical trial. Patient-reported knee pain, function, and quality of life were measured using nine separate patient-reported outcomes. The primary outcomes were the pain subscale of the Knee injury and Osteoarthritis Outcome Score (KOOS) and the average of all five KOOS subscales (KOOS Overall). Treatment cessation was defined as permanent device removal in the MMR group and any surgical procedure to the index knee in the non-surgical care group. RESULTS: Treated subjects had a median age of 52 years old (range 30-69 years) and one or more previous partial meniscectomies at a median of 34 months (range 5-430 months) before trial entry. Among 127 subjects treated with either MMR (n = 61) or non-surgical care (n = 66), 11 withdrew from the trial or were lost to follow-up (MMR, n = 0; non-surgical care, n = 11). The magnitude of improvement from baseline to 1 year was significantly greater in subjects who received MMR in both primary outcomes of KOOS Pain (P = 0.013) and KOOS Overall (P = 0.027). Treatment cessation was reported in 14.5% of non-surgical care subjects and only 4.9% of MMR subjects (n.s.). CONCLUSION: Treatment with the synthetic MMR implant resulted in significantly greater improvements in knee pain, function, and quality of life at 1 year of follow-up compared to treatment with non-surgical care alone. LEVEL OF EVIDENCE: I.

Inconsistencies in Reporting Risk Factors for Medial Patellofemoral Ligament Reconstruction Failure: A Systematic Review.

BACKGROUND: Medial patellofemoral ligament (MPFL) reconstruction is a common surgical treatment for patients with recurrent patellar instability. A variety of risk factors, such as age, trochlear dysplasia, patella alta, and increased tibial tubercle-trochlear groove (TT-TG) distance, have been identified and may lead to postoperative failure or poor outcomes. PURPOSE: While a large number of risk factors have been identified, significant heterogeneity exists in evaluating and reporting these risk factors in the literature. The goal of this study was to perform a systematic review to determine risk factors associated with worse outcomes after MPFL reconstruction and their consistency of being controlled for or analyzed among studies. STUDY DESIGN: Systematic review; Level of evidence, 4. METHODS: A systematic review of the literature was performed using the MEDLINE database to identify relevant clinical outcome studies after MPFL reconstruction for recurrent patellar instability. Eligible studies were evaluated for risk factors that were associated with MPFL failure, defined as recurrent instability or lack of improvement on patient-reported outcome (PRO) scores. Each study was then evaluated for inclusion of these risk factors. RESULTS: Ten studies were included in the final analysis, comprising 1287 knees from 1275 patients who underwent isolated MPFL reconstruction. Of these 10 studies, 8 defined outcomes based on PROs and 3 defined outcomes based on postoperative recurrent instability (1 study included both outcomes). In the PRO failure group, 12 risk factors were found across all studies: trochlear dysplasia, trochlear bump height, elevated TT-TG, patellar tilt, hyperlaxity, age at first dislocation, age at surgery, body mass index, bilateral symptoms, WARPS/STAID score (weak atraumatic, risky anatomy, pain, and subluxation/strong, traumatic, anatomy normal, instability, and dislocation), femoral tunnel malposition, and femoral tunnel widening. In the recurrent instability failure group, 7 risk factors were found across all studies: trochlear dysplasia, bump height, patella alta, higher sulcus angle, higher congruence angle, preoperative J sign, and femoral tunnel malposition. Trochlear dysplasia and femoral tunnel malposition were consistently cited in several studies as risk factors for worse PROs and higher rates of recurrent instability. Patella alta was indicated as a significant risk factor for recurrent instability in 1 of 2 studies analyzing postoperative instability failures and was not associated with worse PROs in any of the studies analyzed. Similarly, elevated TT-TG distance was not a significant risk factor in any of the studies that analyzed recurrent instability as the failure endpoint. CONCLUSION: While various risk factors are postulated to affect outcomes after MPFL reconstruction, there remains inconsistency within the literature regarding the inclusion of all risk factors in a given analysis. Furthermore, the significance of these risk factors varies among studies in terms of whether they affect postoperative outcomes. We found that more severe trochlear dysplasia (types C and D) and femoral tunnel malposition (>10 mm from Schöttle's point) appear to have the most consistent effect on producing higher rates of recurrent dislocation as well as worse PROs. Despite this, the role of concomitant bony procedures to adjust certain pathoanatomic risk factors in addition to MPFL reconstruction remains unknown. Future high-level studies must be conducted that respect the multifactorial nature of patellar instability and should analyze all risk factors (demographic, anatomic, and radiographic) reported to affect outcomes.

Return to Sport After Medial Patellofemoral Ligament Reconstruction: A Systematic Review and Meta-analysis.

BACKGROUND: Patellar instability is frequently encountered in the athletic population. Medial patellofemoral ligament (MPFL) reconstruction is a common strategy to treat recurrent patellar dislocation and demonstrates good clinical outcomes. PURPOSE/HYPOTHESIS: The purpose was to examine return to sport after MPFL reconstruction for patellar instability. We hypothesized that patients would resume athletic activity at a high rate and that a large proportion would return to their preoperative level of performance. STUDY DESIGN: Systematic review and meta-analysis. METHODS: A systematic review of the literature was conducted using PubMed and Cochrane Library databases to identify articles reporting return to sport after MPFL reconstruction for recurrent patellar dislocation. Athletes were defined as those reporting a preoperative sport. A random-effects model was used to evaluate return to sport rates, subsequent level, and rate of instability recurrence. Meta-regression was used to compare return to sport rates in patients undergoing MPFL reconstruction without osteotomy compared with those treated with simultaneous tibial tubercle osteotomy or trochleoplasty. RESULTS: In total, 23 articles met inclusion criteria after full-text review. A total of 930 patients were analyzed, including 786 athletes. Women represented 61.3% of all patients. The overall mean age was 21.1 years (range, 9.5-60.0 years), with a mean follow-up time of 3.0 years (range, 0.8-8.5 years). The return to sport rate was 92.8% (95% CI, 86.4-97.6). Patients returned to or surpassed their preoperative level of activity in 71.3% (95% CI, 63.7-78.4) of cases. An osteotomy was performed on 10.5% of athletes. Return to sport did not differ significantly in patients undergoing MPFL reconstruction without osteotomy versus those receiving additional osteotomy (95.4% vs 86.9%; P = .22). Patients returned to sport at a mean of 6.7 months (range, 3.0-6.4 months) postoperatively. Osteotomy did not affect return time. Complications occurred at an overall rate of 8.8%. The most common complication was recurrence of instability (1.9%; 95% CI, 0.4-4.0). The Kujala score was reported by 13 studies, with pre- and postoperative combined means of 60.3 and 90.0, respectively. CONCLUSION: MPFL reconstruction is an effective and reliable treatment in the setting of patellofemoral instability. Surgeons can counsel their patients that they can expect a high rate of return to sport after MPFL reconstruction surgery alone or with concomitant osteotomy.

Risk of Severe Acute Localized Reactions for Different Intraarticular Hyaluronic Acid Knee Injections in a Real-World Setting.

OBJECTIVE: Case reports of severe acute localized reactions (SALR) following intraarticular (IA) hyaluronic acid (HA) injections for knee osteoarthritis (OA) have been described. We compared surrogate SALR measures between patients using hylan G-F 20 and specific non-hylan G-F 20 HA products. DESIGN: Knee OA patients were identified from the Optum Clinformatics dataset (January 2006 to June 2016), stratified into hylan G-F 20 and non-hylan G-F 20 HA users, matched by single or multiple injection products. Occurrences of surrogate SALR measures including inflammation/infection, intraarticular corticosteroid (CS) injections, arthrocentesis/aspiration, arthrotomy/incision and drainage, and arthroscopy were evaluated within 3 days post-HA. RESULTS: Based on 694,404 HA injections, inflammation/infection rate was rare within 3 days of HA (up to 0.03%), with no statistical differences between hylan G-F 20 and non-hylan G-F 20 groups (matched by single or multiple injection products). The risk of knee arthrotomy/incision and drainage, arthroscopy, or arthrocentesis for hylan G-F 20 (2 mL) 3 weekly injection patients was lower than Hyalgan/Supartz and Orthovisc patients, but greater than Euflexxa patients. Overall, we found that Hylan G-F 20 (2 mL) 3 weekly injection had lower SALR rates compared to Hyalgan/Supartz and Orthovisc. However, Hylan G-F 20 (2 mL) 3 weekly injection had slightly higher rates of SALR when compared to Euflexxa. Among the single injection products, Hylan G-F 20 (6 mL) single injection had lower rates of SALR than Monovisc and Gel-One. CONCLUSIONS: This study shows no clear correlation between avian-derived or cross-linked products and SALR and provides evidence against avian-derived products or crosslinking as a source for these reactions.

Metrics of OsteoChondral Allografts (MOCA) Group Consensus Statements on the Use of Viable Osteochondral Allograft.

BACKGROUND: Osteochondral allograft (OCA) transplantation has evolved into a first-line treatment for large chondral and osteochondral defects, aided by advancements in storage protocols and a growing body of clinical evidence supporting successful clinical outcomes and long-term survivorship. Despite the body of literature supporting OCAs, there still remains controversy and debate in the surgical application of OCA, especially where high-level evidence is lacking. PURPOSE: To develop consensus among an expert group with extensive clinical and scientific experience in OCA, addressing controversies in the treatment of chondral and osteochondral defects with OCA transplantation. STUDY DESIGN: Consensus statement. METHODS: A focus group of clinical experts on OCA cartilage restoration participated in a 3-round modified Delphi process to generate a list of statements and establish consensus. Questions and statements were initially developed on specific topics that lack scientific evidence and lead to debate and controversy in the clinical community. In-person discussion occurred where statements were not agreed on after 2 rounds of voting. After final voting, the percentage of agreement and level of consensus were characterized. A systematic literature review was performed, and the level of evidence and grade were established for each statement. RESULTS: Seventeen statements spanning surgical technique, graft matching, indications, and rehabilitation reached consensus after the final round of voting. Of the 17 statements that reached consensus, 11 received unanimous (100%) agreement, and 6 received strong (80%-99%) agreement. CONCLUSION: The outcomes of this study led to the establishment of consensus statements that provide guidance on surgical and perioperative management of OCAs. The findings also provided insights on topics requiring more research or high-quality studies to further establish consensus and provide stronger evidence.

Workers' Societal Costs After Knee and Shoulder Injuries and Diagnosis with In-Office Arthroscopy or Delayed MRI: A Cost-Minimization Analysis.

The goal of this study was to evaluate the societal costs of using in-office diagnostic arthroscopy (IDA) compared with magnetic resonance imaging (MRI) for the diagnosis of intra-articular knee and shoulder pathology in employed patients receiving Workers' Compensation or disability coverage. The prevalence is estimated at 260,000 total cases per year. METHODS: A cost-minimization analysis of IDA compared with MRI was conducted. Direct costs (in 2018 U.S. dollars) were calculated from private reimbursement amounts and Medicare. Indirect costs were estimated from a societal perspective including effects of delayed surgical procedures on the ability to work, lost income, Workers' Compensation or disability coverage, and absenteeism. Four regions were selected: Boston, Massachusetts; Detroit, Michigan; Denver, Colorado; and San Bernadino, California. Sensitivity analyses were performed using TreeAge Pro 2019 software. The base assumption was that it would take approximately 4 weeks for a diagnosis with MRI and 0 weeks for a diagnosis with IDA. RESULTS: Direct costs to determine a knee diagnosis with IDA were $556 less expensive (California) to $470 more expensive (Massachusetts) than MRI. Assuming a 4-week wait, societal costs (indirect and direct) for knee diagnosis were anywhere from $7,852 (Denver) to $11,227 (Boston) less using IDA. Direct costs were similar for shoulder pathology. In order for MRI to be the less costly option, the MRI and the follow-up visit to the physician would need to occur directly after consultation. Under Medicare, direct costs were similar for both the knee and shoulder when comparing IDA and MRI. Including indirect costs resulted in IDA being the less costly option. CONCLUSIONS: The use of IDA instead of MRI for the diagnosis of knee and shoulder pathology reduced costs. The potential savings to society were approximately $7,852 to $11,227 per operative patient and were dependent on scheduling and follow-up using MRI and on Workers' Compensation. LEVEL OF EVIDENCE: Economic and Decision Analysis Level IV. See Instructions for Authors for a complete description of levels of evidence.

Biologic Association Annual Summit: 2020 Report.

Interest and research in biologic approaches for tissue healing are exponentially growing for a variety of musculoskeletal conditions. The recent hype concerning musculoskeletal biological therapies (including viscosupplementation, platelet-rich plasma, and cellular therapies, or "stem cells") is driven by several factors, including demand by patients promising regenerative evidence supported by substantial basic and translational work, as well as commercial endeavors that complicate the scientific and lay understanding of biological therapy outcomes. While significant improvements have been made in the field, further basic and preclinical research and well-designed randomized clinical trials are needed to better elucidate the optimal indications, processing techniques, delivery, and outcome assessment. Furthermore, biologic treatments may have potential devastating complications when proper methods or techniques are ignored. For these reasons, an association comprising several scientific societies, named the Biologic Association (BA), was created to foster coordinated efforts and speak with a unified voice, advocating for the responsible use of biologics in the musculoskeletal environment in clinical practice, spearheading the development of standards for treatment and outcomes assessment, and reporting on the safety and efficacy of biologic interventions. This article will introduce the BA and its purpose, provide a summary of the 2020 first annual Biologic Association Summit, and outline the future strategic plan for the BA.

Individual Participant Symptom Responses to Intra-Articular Lorecivivint in Knee Osteoarthritis: Post Hoc Analysis of a Phase 2B Trial.

INTRODUCTION: Established thresholds for patient-reported outcomes (PROs) provide clinically relevant responder data from trials. Lorecivivint (LOR) is an intra-articular (IA) therapy in development for knee osteoarthritis (OA). A post hoc analysis from a phase 2b trial (NCT03122860) determined proportions of LOR responders. METHODS: A 24-week, randomized trial of 0.07 mg LOR demonstrated PRO improvements compared with PBO in moderate-to-severe knee OA participants. Participants treated with LOR and PBO achieving 30%/50%/70% improvements at weeks 12 and 24 in Pain Numeric Rating Scale (NRS), WOMAC Pain/Function subscales, Patient Global Assessment (PtGA), and OMERACT-OARSI responder criteria were determined. Odds ratios (ORs) and 95% confidence intervals [CIs] were compared with PBO. RESULTS: There were 115 and 116 participants in the LOR and PBO groups, respectively. For Pain NRS, LOR increased ORs of achieving 30% [week 12, OR = 2.47 (1.45, 4.19), P < 0.001; week 24, OR = 2.37 (1.40, 4.02), P < 0.01] and 50% [week 24, OR = 1.89 (1.11, 3.23), P < 0.05] improvements over baseline. For WOMAC Pain, LOR increased ORs of achieving 30% [week 24, OR = 1.79 (1.06, 3.01), P < 0.05] and 50% [week 12, OR = 1.79 (1.06, 3.03), P < 0.05; week 24, OR = 1.73 (1.02, 2.93), P < 0.05] improvements. For WOMAC Function, LOR increased ORs of achieving 30% [week 12, OR = 1.85 (1.10, 3.12), P < 0.05; week 24, OR = 1.93 (1.14, 3.26), P < 0.05] improvements. For PtGA, LOR increased ORs of achieving 50% [week 12, OR = 2.28 (1.25, 4.16), P < 0.01] improvements. LOR produced numerical increases at the 70% threshold. LOR increased ORs of achieving OMERACT-OARSI responses [week 12, OR = 2.21 (1.29, 3.78); P < 0.01; week 24, OR = 2.57 (1.49, 4.43), P < 0.001] and strict responses [week 12, OR = 2.13 (1.26, 3.61), P < 0.01; week 24, OR = 2.05 (1.21, 3.47), P < 0.01]. CONCLUSIONS: LOR (0.07 mg) demonstrated improved PRO threshold responses across single and composite measures of pain, function, and patient global assessment compared with PBO, with benefits sustained to 24 weeks.

Lorecivivint (LOR) is a new injectable medicine being studied as a treatment for knee osteoarthritis (OA). An early (phase 2b) trial found participants with moderate-to-severe knee OA receiving LOR on average reported improved pain, function, and reduced impact of OA symptoms over 24 weeks compared with placebo. To consider how likely individuals were to respond to treatment, this study analyzed how many participants per group achieved different percentage levels of symptom improvement. Participants were given a single LOR or placebo injection into their most painful (target) knee at trial initiation. Participants reported their target knee status from day 1 (baseline) to week 24 using pain and function questionnaires. We analyzed the number of participants given 0.07 mg LOR and placebo whose symptom scores improved by 30, 50, and 70% over baseline scores at weeks 12 and 24. Results showed that 0.07 mg LOR treatment produced a higher likelihood beyond chance at week 12 of achieving a 30% improvement in some pain and function scores and a 50% improvement in other symptom scores compared with placebo. Similar 30% and 50% symptom score improvements were found at week 24. More complex scores, combining individual symptom scores into single index measures, also showed improvements beyond chance for 0.07 mg LOR from baseline compared with placebo at weeks 12 and 24. Thus, more participants with knee OA who were treated with 0.07 mg LOR demonstrated long-lasting, meaningful improvements in pain and function compared to those given placebo.

Reliability of Radiologic Assessments of Clinically Relevant Growth Remaining in Knee MRI of Children and Adolescents With Patellofemoral Instability: Data From the JUPITER Cohort.

BACKGROUND: Surgical decision making and preoperative planning for children and adolescents with patellofemoral instability rely heavily on a patient's skeletal maturity. To be clinically useful, radiologic assessments of skeletal maturity must demonstrate acceptable interrater reliability and accuracy. PURPOSE: The purpose of this study was to examine the interrater reliability among surgeons of varying experience levels and specialty training backgrounds when evaluating the skeletal maturity of the distal femur and proximal tibia of children and adolescents with patellofemoral instability. STUDY DESIGN: Cohort study (diagnosis); Level of evidence, 3. METHODS: Six fellowship-trained orthopaedic surgeons (3 pediatric orthopaedic, 2 sports medicine, and 1 with both) who perform a high volume of patellofemoral instability surgery examined 20 blinded knee radiographs and magnetic resonance images in random order. They assessed these images for clinically relevant growth (open physis) or clinically insignificant growth (closing/closed physis) remaining in the distal femoral and proximal tibial physes. Fleiss' kappa was calculated for each measurement. After initial ratings, raters discussed consensus methods to improve reliability and assessed the images again to determine if training and new criteria improved interrater reliability. RESULTS: Reliability for initial assessments of distal femoral and proximal tibial physeal patency was poor (kappa range, 0.01-0.58). After consensus building, all assessments demonstrated almost-perfect interrater reliability (kappa, 0.99 for all measurements). CONCLUSION: Surgical decision making and preoperative planning for children and adolescents with patellofemoral instability rely heavily on radiologic assessment of skeletal maturity. This study found that initial interrater reliability of physeal patency and clinical decision making was unacceptably low. However, with the addition of new criteria, a consensus-building process, and training, these variables became highly reliable.