All-inside suture device is superior to meniscal arrows in meniscal repair: a prospective randomized multicenter clinical trial with 2-year follow-up

PURPOSE: Multiple techniques and implants are available for all-inside meniscal repair, but the knowledge about their failure rates and functional outcome is still incomplete. The hypothesis was that there might be differences between meniscal arrows and suture devices regarding reoperation rates and functional outcome. Thereby, the aim of this study was to compare clinical results following repair with the Biofix(®) arrows or the FasT-Fix(®) suture devices. METHODS: In this RCT, 46 patients were treated either by Biofix(®) (n = 21) or FasT-Fix(®) (n = 25). The main outcome was reoperation within 2 years. Knee function and activity level were evaluated by KOOS and Tegner activity scale. RESULTS: Twelve out of 46 (26 %) patients were reoperated within 2 years, nine out of 21 (43 %) in the Biofix(®)-group versus three out of 25 (12 %) in the FasT-Fix(®)-group (p = 0.018). The relative risk of reoperation was 3.6 times higher for Biofix(®) compared to FasT-Fix(®) (95 % confidence interval 1.1–11.5). Both treatment groups had significant increase in all KOOS subscales, but there were no major differences between the groups. The subgroup of reoperated patients differed from the other patients with higher Tegner score preoperatively (median 5 vs. 4) (p = 0.037) and at 3-month follow-up (median 4 vs. 3) (p = 0.010). CONCLUSIONS: These results indicate that FasT-Fix(®) suture is superior to Biofix(®) arrows with significant lower failure rate. Functional outcome did not depend on repair technique. Higher activity score preoperatively and at 3-month follow-up in the reoperated patients indicates that activity level may influence on the risk of reoperation. LEVEL OF EVIDENCE: I.