Evaluating the efficacy and safety of an all-inside, all-suture meniscal repair device on arthroscopic meniscal repair: a prospective, multi-center, randomized controlled clinical trial

Background: To evaluate the efficacy and safety of an all-inside, all-suture meniscal repair device for arthroscopic meniscal repair (AMR). Materials and methods: Patients with vertical longitudinal full-thickness meniscus tears undergoing AMR were randomly assigned to the intervention group (all-inside, all-suture meniscal repair device) or the control group (all-inside meniscal repair system). The primary efficacy endpoint was the Lysholm Knee Score (LKS) at 6 months postoperatively. Secondary efficacy endpoints included: (1) the immediate device success rate at intraoperatively; (2) LKS at 3 and 12 months postoperatively; (3) Tegner activity score (TAS) and visual analogue scale (VAS) of pain at 3, 6, and 12 months postoperatively; (5) Meniscus repair status evaluated by magnetic resonance imaging (MRI) at 6 and 12 months postoperatively. Adverse events (AEs) and device deficiencies were recorded to assess safety. Final follow-up for 12 months was completed in April 2024. Results: A total of 94 patients from 5 tier-A centers in China were randomized (intervention group: n = 48; control group: n = 46). Primary outcome analysis included 91 patients (intervention group: n = 45; control group: n = 46). LKS improved significantly from baseline in both groups at 6 months (both P < 0.001), with no between-group difference in absolute scores (mean ± standard deviation: 90.85 ± 8.70 vs 90.96 ± 11.52, P = 0.503). However, covariance analysis revealed greater LKS improvements in the intervention group (mean ± standard deviation: 30.17 ± 1.65 vs 23.87 ± 1.93, P = 0.015). Safety analysis showed no significant difference in the incidence of surgery-related AEs between the groups (17.02% vs 17.39%, P = 1.000). Conclusion: The all-inside, all-suture meniscal repair device demonstrated comparable efficacy and safety to the controlled all-inside meniscal repair device for arthroscopic repair of vertical longitudinal full-thickness meniscus tears over 12 months. Moreover, it showed superior early improvement in knee function recovery and can be considered an alternative for AMR.