24.1.2 - Synthetic Medial Meniscus Replacement Superior to Non-Surgical Control: 3-Year RCT Results (Pre-Recorded)
- P. Verdonk (Gent-Zwijnaarde, BE)
- W. Gersoff (Denver, US)
- A. Gomoll (New York, US)
- S. Hacker (La Mesa, US)
- E. Hershman (New York, US)
Abstract
Purpose
This research longitudinally tests the clinical trial hypothesis that investigational subjects realize superior improvements in knee-related pain, function, and quality of life, to control subjects, through 3 years of follow-up.
Methods and Materials
242 subjects (176 investigational, 66 control) treated in 2 prospective, concurrent clinical trials in the U.S., and pooled for analysis. Subjects had persistent knee pain and one or more previous partial meniscectomies at least 6 months before trial entry. Patient-reported knee pain, function, and quality of life were assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Treatment cessation was defined as any investigational subject discontinuing the per-protocol treatment by permanent prosthesis removal, or control subjects undergoing any surgical procedure on the index knee. The investigational and control cohorts analyzed were compared at each time point using a two tailed t-test.
Results
The magnitude of improvement from baseline to 3 years was statistically superior in the investigational cohort, compared to the control cohort for all 6 KOOS subscales (Figure 1). Improvement in KOOS Overall and KOOS Pain for the investigational and control cohorts at 3 years were 26.4 vs 10.4 points, and 26.9 vs 15.4 points, respectively. Controls experienced a 35% decline in KOOS Overall improvement between the 2-year and 3-year timepoint (15.9 declined to 10.4). Treatment cessation through 3 years was 31% higher in the control cohort than the investigational cohort (19.6% vs.15.0%).
Conclusion
Results demonstrate statistically and clinically significant superiority for relief of knee pain and improvement in function compared to non-surgical care alone. Between 2 and 3 years, NUsurface KOOS scores remained stable, while Controls regressed. The magnitude of change from baseline to 3 years remained superior for the investigational cohort, even when accounting for subjects undergoing device exchange or repositioning.