ArticleInternational journal of surgery (London, England)2026
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.
Article in International journal of surgery (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundTo evaluate the efficacy and safety of an all-inside, all-suture meniscal repair device for arthroscopic meniscal repair (AMR). MATERIALS AND
methodsPatients 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.
resultsA 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).
conclusionThe 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.
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