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.

Consensus on Rehabilitation Guidelines among Orthopedic Surgeons in the United States following Use of Third-Generation Articular Cartilage Repair (MACI) for Treatment of Knee Cartilage Lesions.

OBJECTIVE: The aim of this study was to evaluate levels of consensus in rehabilitation practices following MACI (autologous cultured chondrocytes on porcine collagen membrane) treatment based on the experience of an expert panel of U.S. orthopedic surgeons. DESIGN: A list of 24 questions was devised based on the current MACI rehabilitation protocol, literature review, and discussion with orthopedic surgeons. Known areas of variability were used to establish 4 consensus domains, stratified on lesion location (tibiofemoral [TF] or patellofemoral [PF]), including weightbearing (WB), range of motion (ROM), return to work/daily activities of living, and return to sports. A 3-step Delphi technique was used to establish consensus. RESULTS: Consensus (>75% agreement) was achieved on all 4 consensus domains. Time to full WB was agreed as immediate (with bracing) for PF patients (dependent on concomitant procedures), and 7 to 9 weeks in TF patients. A progression for ROM was agreed that allowed patients to reach 90° by week 4, with subsequent progression as tolerated. The panel estimated that the time to full ROM would be 7 to 9 weeks on average. A range of time was established for release to activities of daily living, work, and sports, dependent on lesion and patient characteristics. CONCLUSIONS: Good consensus was established among a panel of U.S. surgeons for rehabilitation practices following MACI treatment of knee cartilage lesions. The consensus of experts can aid surgeons and patients in the expectations and rehabilitation process as MACI surgery becomes more prevalent in the United States.

Preliminary Results From a US Clinical Trial of a Novel Synthetic Polymer Meniscal Implant.

BACKGROUND: At least 760,000 outpatient meniscectomies are performed in the United States each year, making this the most common musculoskeletal procedure. However, meniscal resection can alter the joint biomechanics and overload the articular cartilage, which may contribute to degenerative changes and the need for knee replacement. Avoiding or delaying knee replacement is particularly important in younger or more active patients. Synthetic meniscal implants have been developed in an attempt to restore the natural joint biomechanics, alleviate pain and disability, and potentially minimize degenerative changes in patients who require meniscectomy. PURPOSE: To evaluate the preliminary results from 2 ongoing trials that are evaluating the safety and effectiveness of a synthetic polymer meniscal implant (NUsurface; Active Implants, LLC). STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: This was a preliminary analysis of the first 100 patients enrolled across 2 studies for 12 months: a single-arm, intervention-only study and a randomized controlled trial comparing the investigational meniscal implant with nonsurgical therapy. There were 65 patients in the implant group (30 randomized) and 35 in the control group. Outcomes included Knee injury and Osteoarthritis Outcome Score (KOOS) and adverse events (AEs) collected at baseline and follow-up visits of 6 weeks, 6 months, and 12 months. RESULTS: No statistically significant differences were found in baseline characteristics between the implant and control groups. At 12 months, follow-up KOOS data were available for 87% of the 100 included patients. Significantly greater improvements from baseline were observed in the implant group compared with controls in all KOOS subcomponents, except for symptoms (119%-177% greater improvement at 12 months). AEs were reported at similar rates between the 2 groups, with 12 AEs among 11 patients in the implant group (16.9%) versus 5 AEs among 5 patients (14.3%) in the control group (P = .99). CONCLUSION: These preliminary results suggest significant improvements in pain and function scores with the implant over nonsurgical therapy and a similar adverse event rate.

Evaluation of a Novel Degradable Synthetic Biomaterial Patch for Augmentation of Tendon Healing in a Large Animal Model.

Tendon injury is common in sports. The standard of care (SOC) for tendon repair is surgical treatment. However, restored tendons often lack complete strength and functionality, and surgical repair is often unsuccessful. This controlled laboratory study investigates the healing of an Artelon patch (AP)-augmented tendon versus tendon repair alone in a preclinical canine patellar tendon defect model. Full-thickness proximal and distal flap defects were created in the patella tendons of eight purpose-bred research mongrel dogs. Dogs were randomly allocated into either the AP-augmented repair group or the SOC group (N = 8; four knees per group). Outcomes measures included limb function and pain; range of motion (ROM) and ultrasound assessment at 2, 4, and 8 weeks; and measurements of elongation, biomechanical testing, and histology at 8 weeks. Data were compared for statistically significant differences to preoperative measures and between groups (p < 0.05). The AP group had higher limb function scores compared with the SOC group at 2, 4, and 8 weeks, with statistically significant differences observed at 2 weeks (AP: 7.1 ± 1.4, SOC: 5.5 ± 0.4, p < 0.05) and 8 weeks (AP: 9.5 ± 0.7, SOC: 7.0 ± 0.9, p < 0.05). The ROM was significantly higher for the AP group at 4 weeks (AP: 105 degrees ± 4, SOC: 89 degrees ± 5, p < 0.05). Pain scores were statistically significantly lower in the AP group at 4 (AP: 0.6 ± 0.5, SOC: 2.2 ± 0.5) and 8 weeks (p < 0.05 for both comparisons). All animals in the AP group displayed full bridging tissue at week 4, while most animals of the SOC group displayed full bridging by week 8. Minimal tendon elongation was observed in both groups. Significantly more force was required to elongate tendons in the AP group compared with the SOC group (p < 0.05). Animals with AP-augmented tendon repair show an earlier regain of function, earlier regain of range of movement, less postoperative pain, and improved tendon strength when compared with animals treated with tendon repair alone.

International Meniscus Reconstruction Experts Forum (IMREF) 2015 Consensus Statement on the Practice of Meniscal Allograft Transplantation.

Meniscal allograft transplantation (MAT) has become relatively commonplace in specialized sport medicine practice for the treatment of patients with a symptomatic knee after the loss of a functional meniscus. The technique has evolved since the 1980s, and long-term results continue to improve. However, there still remains significant variation in how MAT is performed, and as such, there remains opportunity for outcome and graft survivorship to be optimized. The purpose of this article was to develop a consensus statement on the practice of MAT from key opinion leaders who are members of the International Meniscus Reconstruction Experts Forum so that a more standardized approach to the indications, surgical technique, and postoperative care could be outlined with the goal of ultimately improving patient outcomes.

Meniscal Allograft Transplantation: State of the Art.

Meniscal allograft transplantation has evolved over the years to provide a state-of-the-art technique for the sports medicine surgeon to utilize in preserving contact mechanics and function of the knee in irreparable meniscal pathology. However, this procedure continues to spark considerable debate on proper tissue processing techniques, acceptable indications, methods of implantation, and potential long-term outcomes.

Osteochondral and Meniscal Allograft Transplantation in the Football (Soccer) Player.

Knee injuries are common in football, frequently involving damage to the meniscus and articular cartilage. These injuries can cause significant disability, result in loss of playing time, and predispose players to osteoarthritis. Osteochondral allografting is an increasingly popular treatment option for osteoarticular lesions in athletes. Osteochondral allografts provide mature, orthotopic hyaline cartilage on an osseous scaffold that serves as an attachment vehicle, which is rapidly replaced via creeping substitution, leading to reliable graft integration that allows for simplified rehabilitation and accelerated return to sport. The indications for meniscal replacement in football players are currently still evolving. Meniscus allografts offer potential functional, analgesic, and chondroprotective benefits in the meniscectomized knee. In the player at the end of his or her professional/competitive career, meniscal allografts can play a role in averting progression of chondropenia and facilitating knee function and an active lifestyle. This article is intended to present a concise overview of the limited published results for osteochondral and meniscal allografting in the athletic population and to provide a practical treatment algorithm that is of relevance to the clinician as well as the patient/football player, based on current consensus of opinion.