Mid- to Long-term Results of Single-Bundle Versus Double-Bundle Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial

摘要

Purpose: To evaluate the mid-to long-term results of a randomized controlled trial of single-bundle (SB) versus double-bundle (DB) anterior cruciate ligament (ACL) reconstruction using a semitendinosus tendon. Methods: Seventy-eight patients who underwent primary ACL reconstruction with an autologous semitendinosus tendon were prospectively randomized into 2 groups: SB reconstruction (n = 39) and DB reconstruction (n = 39). In both groups, grafts were fixed at 30 degrees of flexion with a total tension of 80 N. The following evaluation methods were used: clinical examination, KT-1000 arthrometer (MEDmetric, San Diego, CA) measurement, muscle strength, Tegner activity score, Lysholm score, subjective rating scale regarding patient satisfaction and sports performance level, graft retear, contralateral ACL tear, and additional meniscus surgery. Results: Fifty-three patients (25 in SB group and 28 in DB group) who were followed up for a minimum of 3 years (mean, 69 months; range, 36 to 140 months) were evaluated. Preoperatively, there were no differences between the groups. Postoperatively, the Lachman and pivot-shift test results were better in the DB group (P = .024 and P < .0001, respectively). KT measurements were better in the DB group (mean, 1.4 mm v 2.7 mm; P = .0023). The Tegner score was also better in the DB group (P = .033). There were no significant differences in range of motion, muscle strength, Lysholm score, subjective rating scale, graft retear, and secondary meniscal tear. Conclusions: In ACL reconstruction using the transtibial approach, DB reconstruction was significantly better than SB reconstruction regarding anterior and rotational stability during the 3- to 12-year follow-up. The results of KT measurements and the Lachman and pivot-shift tests were significantly better in the DB group, whereas there was no difference in the anterior drawer test results. The Tegner score was also better in the DB group; however, there were no differences in the other subjective findings.