RESUMO
PURPOSE: To compare anatomic single-bundle (SB) with double-bundle (DB) anterior cruciate ligament reconstruction (ACL-R) and to evaluate the respective clinical outcome results. METHODS: In a prospective randomized study, 64 patients were included and separated into 2 groups. Anatomic SB and DB ACL-Rs were performed with hamstring tendons. Five years after surgery, the follow-up (FU) examination comprised International Knee Documentation Committee (IKDC) 2000, Laxitester (ORTEMA Sport Protection, Markgroeningen, Germany) measurement, and radiograph evaluation. Power calculation was performed to achieve a 95% confidence interval and 80% power on the base of 7-point IKDC subjective difference between the groups. RESULTS: A total of 53 patients (83% FU) were examined at 63.2 ± 4.7 months after surgery: 28 patients in the DB group and 25 patients in the SB group. IKDC subjective (SB: 92.8 ± 6.2, DB: 91.6 ± 7.1; P = .55) and objective scores (grade A SB/DB 20%/25%, B SB/DB 72%/57%, C SB/DB 8%/18%, D SB/DB 4%/0%; P = .45) showed no differences comparing both groups. The Laxitester measurements showed no significant difference in regard to anterior-posterior translation in neutral, internal, and external rotation or to rotation angles (P = .79). No difference was seen between the groups regarding osteoarthritic changes and tunnel widening. CONCLUSIONS: At the 5-year FU, no advantage for either the DB or SB technique in ACL-R can be seen with regard to patient-related and objective outcome measures. LEVEL OF EVIDENCE: Level I, prospective randomized controlled clinical trial.
