RESUMO
PURPOSE: The aim of this study was to assess graft failure, revision rate, and functional outcomes after treatment of acute ACL rupture with dynamic intraligamentary stabilization (DIS) Ligamys device one year post surgery. Additionally, differences in functional outcome between patients with and without anteroposterior laxity were assessed. It was hypothesized that the failure rate of DIS was non-inferior to that of previously reported ACL reconstruction (10%). METHODS: In this prospectively designed multicenter study, including patients with an acute ACL rupture, DIS was performed within 21 days after rupture. Primary outcome was failure of the graft at 1 year post surgery, defined as 1) re-rupture of the graft, 2) revision of DIS, or 3) a > 3 mm side-to-side difference in anterior tibial translation compared to the non-operated knee (∆ATT), measured by the KT1000 device. Additional analysis was performed using a 5 mm threshold. The subjective International Knee Documentation Committee Score (IKDC) and Numerical Rating Scales (NRS) for pain and confidence were used to evaluate functional outcome. RESULTS: A total of 155 patients were included with a mean age at surgery of 27.8 years (SD 9.4). The mean interval from rupture to DIS was 16.4 days (SD 5.2). At a median follow-up of 13 months (IQR 12-18) the failure rate of the graft was 30.2% (95%CI:22.0-39.4); 11 patients (7%) required secondary reconstructive surgery and of the 105 patients who attended ATT measurement, 24 patients (23%) had an ∆ATT > 3 mm. Secondary analysis, based on a 5 mm threshold, revealed a failure rate of 22.4% (95%CI: 15.2; 31.1). A total of 39 patients (25%) reported at least one complication, comprising mainly arthrofibrosis, traumatic re-rupture and pain. In these patients, removal of the monoblock was performed in 21 cases (13.5%). At follow-up no significant differences in functional outcomes between patients with ∆ATT > 3 mm and stable ATT were observed. CONCLUSION: This prospective multicenter study found a high failure rate at one year follow-up of 30% (7% revision surgery and 23% > 3 mm side-to-side difference in anterior tibial translation) in patients treated by primary repair of the ACL with DIS, and did therefore not demonstrate non-inferiority to ACL reconstruction. For patients who did not require secondary reconstructive surgery, this study found good functional outcomes, also in case of persistent anteroposterior knee laxity (∆ATT > 3 mm). LEVEL OF EVIDENCE: Level IV.
