PMID- 33062765 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20220417 IS - 2325-9671 (Print) IS - 2325-9671 (Electronic) IS - 2325-9671 (Linking) VI - 8 IP - 9 DP - 2020 Sep TI - Preliminary Results From a US Clinical Trial of a Novel Synthetic Polymer Meniscal Implant. PG - 2325967120952414 LID - 10.1177/2325967120952414 [doi] LID - 2325967120952414 AB - 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. CI - (c) The Author(s) 2020. FAU - McKeon, Brian P AU - McKeon BP AD - Boston Sports & Shoulder Center, Waltham, Massachusetts, USA. FAU - Zaslav, Kenneth R AU - Zaslav KR AD - Ortho Virginia, Virginia Commonwealth University, Richmond, Virginia, USA. FAU - Alfred, Richard H AU - Alfred RH AD - The Bone & Joint Center and Albany Medical College, Albany, New York, USA. FAU - Alley, R Maxwell AU - Alley RM AD - The Bone & Joint Center and Albany Medical College, Albany, New York, USA. FAU - Edelson, Richard H AU - Edelson RH AD - Sports Medicine Oregon, Tigard, Oregon, USA. FAU - Gersoff, Wayne K AU - Gersoff WK AD - Advanced Orthopedic and Sports Medicine Specialists, Denver, Colorado, USA. FAU - Greenleaf, Jonathan E AU - Greenleaf JE AD - Sports Medicine Oregon, Tigard, Oregon, USA. FAU - Kaeding, Christopher C AU - Kaeding CC AD - Sports Medicine Institute and Department of Orthopaedics, The Ohio State University Wexner Medical Center, Columbus, Ohio, USA. LA - eng PT - Journal Article DEP - 20200929 PL - United States TA - Orthop J Sports Med JT - Orthopaedic journal of sports medicine JID - 101620522 PMC - PMC7536377 OTO - NOTNLM OT - NUsurface OT - knee OT - meniscal injury OT - meniscal replacement OT - meniscectomy OT - meniscus OT - synthetic meniscal implant COIS- One or more of the authors has declared the following potential conflict of interest or source of funding: All authors are investigators in a randomized controlled trial or single-arm study of NUsurface and have received research funding and support from Active Implants for conduct of those trials. A technical writing and editing service (Telos Partners, LLC) was provided funding by Active Implants to support the authors in completing and submitting this manuscript. B.P.M. has received educational support from Biomet, honoraria from Arthrosurface, consulting fees from DePuy, and speaking fees from Conformis; has stock/stock options in Conformis; and is a minority owner of Boston Outpatient Surgical Suites. K.R.Z. has received speaking fees from Aastrom Biosciences, consulting fees from Aesculap Biologics and Bioventus, and educational support from Vericel and Supreme Orthopedic Systems. R.M.A. has received hospitality payments from Prodigy Surgical. W.K.G. has received consulting fees from Bacterin International, Aastrom Biosciences, Vericel, RTI Surgical, and Stryker; speaking fees from Sanofi-Aventis, Aastrom Biosciences, and Vericel; honoraria from Aastrom Biosciences and Vericel; and has stock/stock options in Bacterin International. J.E.G. has received hospitality payments from Arthrex, Conformis, and Stryker and honoraria from Arthrosurface. C.C.K. has received consulting fees from Zimmer Biomet, speaking fees from Arthrex, educational support from CDC Medical, and grant support from DJO. AOSSM checks author disclosures against the Open Payments Database (OPD). AOSSM has not conducted an independent investigation on the OPD and disclaims any liability or responsibility relating thereto. EDAT- 2020/10/17 06:00 MHDA- 2020/10/17 06:01 PMCR- 2020/09/29 CRDT- 2020/10/16 05:56 PHST- 2020/03/18 00:00 [received] PHST- 2020/04/09 00:00 [accepted] PHST- 2020/10/16 05:56 [entrez] PHST- 2020/10/17 06:00 [pubmed] PHST- 2020/10/17 06:01 [medline] PHST- 2020/09/29 00:00 [pmc-release] AID - 10.1177_2325967120952414 [pii] AID - 10.1177/2325967120952414 [doi] PST - epublish SO - Orthop J Sports Med. 2020 Sep 29;8(9):2325967120952414. doi: 10.1177/2325967120952414. eCollection 2020 Sep.