Prospective randomized comparison of double-bundle versus single-bundle anterior cruciate ligament reconstruction.

PURPOSE: Biomechanical studies show increased anterior and rotational stability with double-bundle (DB) compared to single-bundle (SB) anterior cruciate ligament (ACL) reconstruction. The aim of this study was to evaluate the clinical results of four-tunnel DB ACL reconstruction.
METHODS: Seventy patients undergoing arthroscopic hamstring ACL reconstruction were prospectively randomized to DB (n = 35) or SB (n = 35) groups. Each bundle fixation was by means of a femoral EndoButton CL and a tibial biodegradable interference screw. Demographic data were comparable between groups, and the average age of all patients was 29 years. The average follow-up was 19 months for both groups and included a history, clinical evaluation with knee scores, and radiographs.
RESULTS: The subjective results were similar in groups. The subjective International Knee Documentation Committee (IKDC) 2000 score was 88 P for DB versus 90 P for SB; the Lysholm score was 90 P for DB versus 93 P for SB; and the Cincinnati knee score was 91 P for DB versus 92 P for SB. The objective IKDC was significantly higher for DB: 78% "A" (P < .000) and 19% "B" compared to 24% "A" and 68% "B" for SB. The average KT-1000 side-to-side difference was 1.0 mm for DB and 1.6 mm for SB (P = .054) and the pivot shift test was negative in 97% for DB (P = .01) and 71% for SB. The range of motion was comparable for both groups.
CONCLUSIONS: Our study shows a significant advantage in anterior and rotational stability as well as objective IKDC for four-tunnel DB ACL reconstruction compared to SB ACL reconstruction. The subjective Cincinnati knee score, the Lysholm score, and the subjective IKDC 2000 did not show any statistical difference for one or the other technique. LEVEL OF EVIDENCE: Level I, randomized controlled trial.

RCT Entities:   Population Interventions Outcomes