Anatomic single-bundle anterior cruciate ligament reconstruction using a calcium phosphate-hybridized tendon graft: a randomized controlled trial with 2 years of follow-up

BACKGROUND: To improve tendon-to-bone healing in anterior cruciate ligament (ACL) reconstruction, a novel technique via calcium phosphate (CaP)-hybridized tendon graft using an alternate soaking process was developed. The purpose of this study was to evaluate the clinical results of anatomic single-bundle ACL reconstruction using the CaP-hybridized tendon graft with up to 2 years follow-up, and compare the outcome with conventional ACL reconstruction and preoperative data. METHODS: Ninety patients who required anatomic single-bundle ACL reconstruction were randomized to undergo either the CaP-hybridized tendon graft method (CaP group, n = 45) or the conventional method (conventional group, n = 45). At 1 and 2 years postoperatively, all patients were evaluated using KT-1000 arthrometry, pivot-shift test, International Knee Documentation Committee (IKDC) grade, Lysholm scale, and Tegner scale; at the same timepoints, bone tunnel enlargement was evaluated using computed tomography, and the tendon graft intensity was evaluated on magnetic resonance imaging. Tendon graft appearance was evaluated arthroscopically once after a period of up to 2 years postoperatively. Cases of re-rupture and adverse events were recorded in both groups. RESULTS: In both groups, the KT-1000 arthrometry, pivot-shift test, IKDC grade, and Lysholm scale results at 1 and 2 years postoperatively were superior to preoperative data; these results did not significantly differ between groups at either timepoint. The rate of increase of the cross-sectional area of the femoral bone tunnel in the CaP group was smaller than that in the conventional group at 1 year postoperatively. The other results did not significantly differ between the two groups at any timepoint. There were two cases of re-rupture in the CaP group, and six cases of re-rupture in the conventional group. There were no adverse events during follow-up in either group. CONCLUSIONS: Anatomic single-bundle ACL reconstruction using a CaP-hybridized tendon graft was safe, and resulted in improved clinical outcomes at 2 years postoperatively compared with preoperative data; the outcomes were comparable with the conventional method. A longer follow-up is needed to clarify the clinical effects of the CaP-hybridized tendon graft in anatomic single-bundle ACL reconstruction. TRIAL REGISTRATION: UMIN, UMIN000019788 Registered 14 November 2015—Retrospectively registered.