Long-Term Outcomes of Primary Anterior Cruciate Ligament Reconstruction Using Achilles Tendon Allograft.

PURPOSE: This study sought to assess the long-term structural integrity of primary anterior cruciate ligament (ACL) reconstructions using Achilles tendon allografts by measuring the side-to-side difference in anterior-posterior tibial translation between the operative knee and the contralateral, asymptomatic knee. METHODS: This study was a retrospective case series consisting of patients who underwent primary ACL reconstruction with Achilles tendon allograft. Allografts were chemically processed using the AlloWash or AlloTrue methods and then received either gamma radiation or electron beam radiation (range: 0.95 to 1.4 Mrad dose). At the time of follow-up, anterior-posterior tibial translation of both the operative and contralateral knees was measured using the Lachmeter® device. Functional outcomes were assessed using the International Knee Documentation Committee (IKDC) questionnaire and the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. RESULTS: The analysis included 20 patients (mean age: 41.38 ± 14.27 years) with a mean follow-up time of 7.01 ± 5.24 years. There were no graft failures requiring revision during the study period. The mean side-to-side difference in laxity between operative and contralateral knees was 1.10 ± 2.02 mm. Two patients (10%) met the criteria for complete ACL injury at the time of follow-up, while the remaining 18 patients (90%) met the criteria for no ACL injury. The mean IKDC score was 83.5 ± 13.8, and mean KOOS score was 88.4 ± 10.7. CONCLUSIONS: Primary ACL reconstruction using an Achilles tendon allograft in skeletally mature patients resulted in maintained knee stability and good functional outcomes over the long-term postoperative period.

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.

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.

Online Direct-to-Consumer Advertising of Stem Cell Therapy for Musculoskeletal Injury and Disease: Misinformation and Violation of Ethical and Legal Advertising Parameters.

BACKGROUND: There has been a recent surge in health-care providers offering stem cell therapy (SCT) to patients with musculoskeletal disease. The purpose of this study was to identify and quantify the misinformation present in online direct-to-consumer (DTC) advertising of SCT targeting patients with musculoskeletal disease in the U.S. It was hypothesized that DTC advertising of SCT contains substantial misinformation. METHODS: A list of keywords was used to identify web sites of practices advertising SCT directly to patients with musculoskeletal disease. Web sites were evaluated to determine the specialties of providers offering SCT, types of SCT being advertised, and misinformation presented. Categories of misinformation included false general claims, inaccurate statements regarding mechanism of action, unfounded results, and scare tactics. RESULTS: Of the 896 practice web sites included in the analysis, 95.9% contained at least 1 statement of misinformation, with a mean of 4.65 ± 3.66 statements of misinformation among the sites. Practices associated with an orthopaedic surgeon provided 22% fewer statements of misinformation than practices without an orthopaedic surgeon when we controlled for the effects of other specialties. Practices associated with a podiatrist also provided 22% fewer statements of misinformation. CONCLUSIONS: Nearly all practices failed to accurately represent the clinical efficacy of SCT in DTC advertising. While practices associated with an orthopaedic surgeon were less likely to provide misinformation, the majority of all web sites contained some type of misinformation, ranging from errors in the basic science of stem cells to outright false and misleading claims of their clinical effectiveness.