Effects of Initial Graft Tension and Patient Sex on Knee Osteoarthritis Outcomes After ACL Reconstruction: A Randomized Controlled Clinical Trial With 10- to 12-Year Follow-up

Background: The initial graft tension applied during anterior cruciate ligament (ACL) graft fixation may promote posttraumatic osteoarthritis (PTOA). Purpose/Hypothesis: This study sought to assess the effect of initial graft tension and patient sex on PTOA outcomes at 10 to 12 years after ACL reconstruction (ACLR). The hypothesis was that there would be no group- or sex-based differences in outcomes. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients were randomized to receive ACLR with a low or high initial graft tension. Outcomes were evaluated at 10 to 12 years postoperatively and compared with a matched, uninjured control group. Outcomes included clinical assessments (anteroposterior [AP] knee laxity measurement, International Knee Documentation Committee [IKDC] examination score), a functional assessment (single-leg hop for distance), patient-reported outcomes (Knee injury and Osteoarthritis Outcome Score [KOOS], 36-Item Short Form Health Survey, Tegner activity level, patient satisfaction), and PTOA imaging (Osteoarthritis Research Society International [OARSI] radiographic score and Whole-Organ Magnetic Resonance Imaging Score [WORMS]). Two-way mixed-model analyses of variance were used to evaluate differences in outcomes between tension groups and the control group and between female and male patients. Results: Both tension groups scored worse than the control group for the IKDC examination ( P≤ .021), KOOS (Pain, Activities of Daily Living, Sport/Recreation, and Quality of Life subscales) ( P≤ .049), and WORMS difference score ( P≤ .042). The low-tension group scored worse than the control group for KOOS Symptoms ( P = .016) and the OARSI difference score ( P = .015). The index limb had worse scores than the contralateral limb within the high-tension group for AP laxity ( P = .030) and hop deficit ( P = .011). This result was also observed within both tension groups for the WORMS ( P≤ .050) and within the low-tension group for the OARSI score ( P = .001). Male patients had higher Tegner scores (mean ± SE) relative to female patients (male, 5.49 ± 1.88; female, 4.45 ± 1.65) and worse OARSI difference scores (male, 1.89 ± 5.38; female, 0.244 ± 0.668) ( P = .007 and .034, respectively). However, no significant differences were detected between tension groups for any of the outcomes measured. Conclusion: Overall, ACLR failed to prevent PTOA regardless of initial graft tension. However, male patients treated with a low initial graft tension may be at greater risk for PTOA. These results do not support the hypothesis of no sex differences in outcomes at 10 to 12 years after ACLR.