Double-bundle versus single-bundle anterior cruciate ligament reconstruction: a prospective, randomize clinical study.

Anatomical observation and biomechanical studies have shown that the anterior cruciate ligament (ACL) mainly consists of two distinct bundles, the anteromedial (AM) bundle and posterolateral (PL) bundle. Conventional single-bundle ACL reconstruction techniques have focused on the restoration of the AM bundle while giving limited attention to the PL bundle. The purpose of this prospective, randomized clinical study is to compare the outcomes of ACL reconstruction when using either double-bundle or single-bundle technique and bioabsorbable interference screw fixation, and similar rehabilitation with both techniques. Sixty-five patients were randomized into either double-bundle (n = 35) or single-bundle (n = 30) ACL reconstruction with hamstring tendons and bioabsorbable screw (Hexalon, Inion Company, Tampere, Finland) fixation in both groups. The evaluation methods were clinical examination, KT-1000 arthrometer measurements, radiographic evaluation, as well as International Knee Documentation Committee and Lysholm knee scores. There were no differences between the study groups preoperatively. For an average of 14 months of follow-up (range 12-20 months), 30 patients of the double-bundle group and 29 patients of the single-bundle group were available (91%). At the follow-up, the rotational stability, as evaluated by pivot shift test, was significantly better in the double-bundle group than in the single-bundle group. However, in anterior stability of the knee, there was no significant difference between the groups. None of the patients in the double-bundle group had graft failure, while four patients in the single-bundle group had. In addition, knee scores were equal at the follow-up, and all the results were significantly better at the follow-up than preoperatively, in both groups.

RCT Entities:   Population Interventions Outcomes