Osteoconductive Scaffold Placed at the Femoral Tunnel Aperture in Hamstring Tendon ACL Reconstruction: A Randomized Controlled Trial

Abstract

Background: Bone tunnel enlargement after single-bundle anterior cruciate ligament reconstruction remains an unsolved problem that complicates revision surgery. Hypothesis: Positioning of an osteoconductive scaffold at the femoral tunnel aperture improves graft-to-bone incorporation and thereby decreases bone tunnel widening. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: In a 1:1 ratio, 56 patients undergoing primary anterior cruciate ligament reconstruction were randomized to receive femoral fixation with cortical suspension fixation and secondary press-fit fixation at the tunnel aperture of the tendon graft only (control) or with augmentation by an osteoconductive scaffold (intervention). Adverse events, patient-reported outcomes, and passive knee stability were recorded over 2 years after the index surgery. Three-dimensional bone tunnel widening was assessed using computed tomography at the time of surgery and 4.5 months and 1 year postoperatively. Results: The intervention group exhibited a similar number of adverse events as the control group (8 vs 10; P = .775) including 2 partial reruptures in both groups. The approach was feasible, although 1 case was encountered where the osteoconductive scaffold was malpositioned without adversely affecting the patient’s recovery. There was no difference between the intervention and control groups in femoral bone tunnel enlargement, as expressed by the relative change in tunnel volume from surgery to 4.5 months (mean ± SD, 36% ± 25% vs 40% ± 25%; P = .644) and 1 year (19% ± 20% vs 17% ± 25%; P =.698). Conclusion: Press-fit graft fixation with an osteoconductive scaffold positioned at the femoral tunnel aperture is safe but does not decrease femoral bone tunnel enlargement at postoperative 1 year. Registration: NCT03462823 ( ClinicalTrials.gov identifier).