Health-related quality of life and direct costs in patients with anterior cruciate ligament injury: single-bundle versus double-bundle reconstruction in a low-demand cohort--a randomized trial with 2 years of follow-up.

PURPOSE: To evaluate health-related quality of life (HRQL) in patients undergoing anterior cruciate ligament (ACL) reconstructive surgery by use of 2 procedures and to estimate the direct costs of surgery.

METHODS: We performed a 2-year randomized, prospective intervention study of 2 surgical ACL reconstruction techniques (anatomic single bundle [SB] v double bundle [DB]). Fifty-five consecutive outpatients, with a mean age of 30.88 years, were randomized to SB or DB ACL reconstruction. The Medical Outcomes Study 36-item Short Form Health Survey (SF-36) was used to measure HRQL (primary outcome). ACL injuries were assessed by the International Knee Documentation Committee (IKDC) score (secondary outcome). The use of medical resources and their costs were evaluated.

RESULTS: We included 52 patients in the final analyses (23 in the SB group and 29 in the DB group). At baseline, there were no significant differences in study variables. At 2 years of follow-up, there were no significant differences in SF-36 and IKDC scores between groups. However, compared with baseline, the SF-36 physical function, physical role, bodily pain, social function, and emotional role scores were significantly better in the SB group (P < .05), whereas only the physical function dimension score was better in the DB group (P = .047). IKDC scores at 2 years improved significantly in the SB group (P < .001) and DB group (P = .004) compared with baseline. There was a significant correlation between the SF-36 physical function, physical role, and bodily pain dimensions and the IKDC score at 2 years (P < .05). The costs were € 3,251 for the SB group and € 4,172 for the DB group.

CONCLUSIONS: HRQL and medical outcomes were similar between SB and DB ACL reconstruction techniques, 2 years after surgery. However, the SB technique was more cost-effective.