Ten-Year Patient-Reported, Clinical, and Radiological Outcomes of a Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle Anterior Cruciate Ligament Reconstructions

This prospective, double-blind randomized clinical trial compares disease-specific quality-of-life, clinical and radiographic outcomes 10-years following ACL reconstruction with patellar tendon, single-bundle quadruple-stranded hamstring, or double-bundle hamstring tendon constructs. Three-hundred-and-thirty ACL deficient patients (183 males; 14–50 years) were intra-operatively randomized (computer-generation, varied-blocks) to ACL reconstruction with a patellar tendon (PT, n=110, mean 28.7 years), single-bundle quadruple-stranded semitendinosis-gracilis tendon (HT, n=110, mean 28.5 years), or 2-stranded semitendinosis and 2-stranded gracilis tendon double-bundle graft (DB, n=110, mean 28.3 years). An independent trained examiner and patients were blinded to treatment allocation. Outcomes were assessed at Baseline, 2-, 5- and 10-years post-operatively. Primary outcome: patient-reported ACL Quality-of-Life (ACL-QOL) score. Secondary outcomes: pivot shift, kneeling pain, International Knee Documentation Committee (IKDC) Objective scores, Tegner Activity, and Single-Leg Hop test. A blinded assessor graded medial, lateral and patellofemoral compartments using the IKDC radiographic scale; categorized as Absence (A/B) or Presence (C/D) of osteoarthritis (OA). Proportions of traumatic re-injuries (combined complete and partial re-ruptures), and contralateral tears were compared. Analysis of variance for repeated measures, with 95% Confidence Intervals (95%CI) was used for continuous data, and Chi-square analyses for categorical data. Multi-variable logistic regression models identified predictors of medial and lateral radiographic OA. A 5% significance level was used for all analyses. Two-hundred-and-eighty-seven patients (87%) completed 10-year follow-up (mean 10.2±1.2 years). Six patients withdrew, 1 deceased, and 36 patients were lost-to-follow-up. Mean ACL-QOL scores (Figure 1) increased over time for all groups (p ±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). At 10-years, fewer traumatic re-injuries occurred with PT grafts (PT=8%; HT=22%; DB=21%, p=0.023). There were no differences between groups 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). At 10-years, 45% of patients had radiographic OA in at least one compartment (medial 17%; lateral 29%; patellofemoral 6%). ACL-QOL scores were significantly lower for patients with medial (69.3±3.2) and lateral radiographic OA (72.8±2.4) than those without OA (adjusted mean differences 10.2±3.5 (p=0.004) and 7.2±2.9 (p=0.01), respectively). The PT group had significantly more lateral radiographic OA (PT=42%, HT=23%, DB=23%; p=0.010); but no differences in medial (PT=14%, HT=12%, DB=24%, p=0.094) or patellofemoral OA (PT=5%, HT= 7%, DB=8%, p=0.782). Predictive factors of medial radiographic OA at 10-years included: age, meniscectomy, chondral damage and secondary surgery. Predictive factors of lateral radiographic OA included: PT graft, valgus alignment and meniscectomy (Table 1). At 10-years, there was no difference in disease-specific ACL-QOL outcome between graft types. Patients with medial and lateral OA had lower ACL-QOL scores. More traumatic re-injuries and higher-grade pivot shift tests occurred with HT and DB reconstructions. However, patients with PT reconstructions were more likely to have radiographic changes in the lateral compartment. Age, meniscectomy, chondral damage and secondary surgery were predictive of medial radiographic OA. PT graft, valgus alignment and meniscectomy were predictive of lateral OA at 10-years. For any figures or tables, please contact the authors directly.