Quality-of-life outcomes and osteoarthritis development at 10-years after anterior cruciate ligament reconstruction: A large randomized clinical trial comparing patellar tendon, hamstring tendon and double-bundle grafts.

INTRODUCTION: This large randomized clinical trial compared disease-specific quality-of-life, clinical and radiographic outcomes 10-years following Anterior Cruciate Ligament (ACL) reconstruction with patellar tendon (PT), single-bundle (HT; quadruple-stranded semitendinosis-gracilis/tendons), or double-bundle (DB; 2-stranded semitendinosis and 2-stranded gracilis tendon) hamstring tendon constructs. METHODS: Three-hundred-and-thirty ACL deficient patients (183 males; 14-50 years) were randomized to PT (n=110, mean 28.7 years), single-bundle HT (n=110, mean 28.5 years), or double-bundle DB, (n=110, mean 28.3 years). An independent assessor and patients were blinded to treatment allocation up to 2-years. Outcomes were assessed at Baseline, 2-, 5- and 10-years post-operatively. PRIMARY OUTCOME: ACL Quality-of-Life (ACL-QOL) score. SECONDARY OUTCOMES: pivot shift, kneeling pain, International Knee Documentation Committee (IKDC) scores, Tegner Activity Level, traumatic re-injuries and contralateral ACL tears. A blinded assessor graded each knee compartment using the International Knee Documentation Committee (IKDC) radiographic scale. RESULTS: Two-hundred-and-eighty-seven patients (87%) completed 10-year follow-up (mean 10.2 1.2 years). Mean ACL-QOL scores increased over time for all groups (p<0.001), with no statistically significant difference at 10-years (PT=76.4 21.0 (95%CI 72.1-80.7); HT=77.7 20.5 (95%CI 73.4-81.9); DB=77.3 21.5 (95%CI 73.0-81.7); p=0.912). Fewer traumatic re-injuries occurred with PT grafts (PT=8%; HT=22%; DB=21%, p=0.023). No statistically significant differences for contralateral ACL tears (PT=13%; HT=13%; DB=10%; p=0.801), kneeling pain (PT=6%; HT=4%; DB=7%; p=0.637), Normal/Nearly Normal IKDC Objective scores (PT=73%; HT=68%; DB=72%; p=0.724) or the remaining secondary outcomes. Pivot shift grade ≥2 was less likely with a PT reconstruction (PT=18%; HT=25%; DB=24%; p=0.584). Forty-five percent of patients had radiographic OA at 10-year follow-up (medial=17%; lateral=29%; patellofemoral=6%). ACL-QOL scores were statistically significantly lower for patients with medial (69.3 3.2) and lateral OA (72.8 2.4). The PT group had more lateral OA (PT=42%, HT=23%, DB=23%; p=0.010), but no statistically significant differences in medial (PT=14%, HT=12%, DB=24%, p=0.094) or patellofemoral OA (PT=5%, HT=7%, DB=8%, p=0.782). Contributors of medial OA included baseline age, medial meniscectomy, chondral damage and subsequent secondary surgery. Contributors of lateral OA included PT graft, valgus alignment and lateral meniscectomy. ConclusionsACL reconstructive surgery consistently improves quality-of-life, with most patients remaining highly active at 10 years. ACL-QOL scores were lower for patients with medial and lateral OA. More traumatic re-injuries occurred with HT and DB reconstructions. PT reconstructions were more likely to have lateral radiographic changes. All effect sizes demonstrating these associations were small. LEVEL OF EVIDENCE: Level 1 CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov # ID number.