Effect of Matching or Overconstraining Knee Laxity During Anterior Cruciate Ligament Reconstruction on Knee Osteoarthritis and Clinical Outcomes: A Randomized Controlled Trial With 84-Month Follow-up.

BACKGROUND: The "initial graft tension" applied at the time of graft fixation during anterior cruciate ligament (ACL) reconstruction surgery modulates joint contact mechanics, which in turn may promote posttraumatic osteoarthritis (OA). PURPOSE/HYPOTHESES: The study objectives were to compare clinical, functional, patient-reported, and OA imaging outcomes between 2 different initial laxity-based graft tension cohorts and a matched uninjured control group as well as to evaluate the effects of laxity-based graft tension on OA development at 84-month follow-up. The 2 laxity-based tension protocols were (1) to restore normal anteroposterior (AP) laxity at the time of surgery relative to the contralateral uninjured knee (low-tension group) or (2) to overconstrain AP laxity by 2 mm relative to the contralateral uninjured knee (high-tension group). The hypotheses were that (1) the high-tension group would have improved outcomes and decreased OA compared with the low-tension group after 84 months, and (2) the outcomes for the high-tension group would be equivalent to those for an age-, sex-, race-, and activity-matched group of control participants with uninjured knees. STUDY
DESIGN: Randomized controlled trial; Level of evidence, 1.
METHODS: Patients had their ACLs reconstructed with either a bone-patellar tendon-bone or 4-stranded hamstring autograft, and outcomes were compared with a matched control group. Outcomes were evaluated preoperatively and at 60 and 84 months postoperatively and included clinical (KT-1000 arthrometer AP laxity measurement and International Knee Documentation Committee [IKDC] examination score), functional (1-legged hop for distance and knee extensor torque), patient-reported (Knee injury and Osteoarthritis Outcome Score [KOOS], Short Form-36 [SF-36], and patient satisfaction survey), and OA imaging (measurement of joint space width [JSW], Osteoarthritis Research Society International [OARSI] radiographic score, and Whole-Organ Magnetic Resonance Imaging Score [WORMS]) components. Repeated-measures analyses of variance were used to evaluate differences in outcomes between the treatment groups and the control group.
RESULTS: There were significant differences between the 2 tension groups in 1 of 5 KOOS subscales (sports and recreation; P = .04) and 2 of 8 SF-36 subscales (vitality, mental health; P < .04) at 84 and 60 months, respectively. Both tension groups scored significantly worse than the control group in the IKDC examination (P < .001), 1-legged hop (P ≤ .017), KOOS quality of life and symptoms subscales (P < .03), and OARSI radiographic score (P ≤ .02) at 84 months. The low-tension group performed significantly worse than the control group on the KOOS pain subscale (P = .03), SF-36 general health and social functioning (P < .04), OARSI radiographic score (P < .001), and WORMS (P = .001), while the high-tension group had statistically different results than the control group in AP knee laxity (P < .001), radiographic JSW (P = .003), and OARSI radiographic score (P = .02) as well as significantly more subsequent knee injuries (P = .02) at 84 months.
CONCLUSION: The results do not support the hypotheses that the high-tension group would have improved outcomes when compared with the low-tension group after 84 months of healing or that the outcomes for the high-tension group would be equivalent to those for the matched control group. While there were minor differences in patient-reported outcomes between the 2 laxity-based tension groups, all other outcomes were similar. REGISTRATION: NCT00434837.

RCT Entities:   Population Interventions Outcomes