2025 ISAKOS Biennial Congress Paper
Ten Year Patient Reported Clinical and Radiographic Outcomes of a Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon and Double-Bundle ACL Reconstructions
Nick Mohtadi, MD, MSc, FRCSC, DRCPSC, Clinical Professor, Calgary, AB CANADA
Denise S. Chan, MBT, MSc, Calgary, AB CANADA
Pablo Bertiche, MD, Cordoba, Cordoba ARGENTINA
Dana J Hunter, BA, MSc, Calgary, Alberta CANADA
Hana Marmura, MPT, PhD, Durham, NC UNITED STATES
Dianne M. Bryant, PhD, London, ON CANADA
University of Calgary Sport Medicine Centre, Calgary, Alberta, CANADA
FDA Status Not Applicable
Summary
The largest prospective, double-blind randomized clinical trial comparing patient-reported quality-of-life, clinical and radiographic outcomes at 10-years following Anterior Cruciate Ligament (ACL) reconstruction with patellar tendon, single-bundle hamstring tendon or double- bundle hamstring tendon autografts.
Abstract
Purpose
This prospective, double-blind randomized clinical trial compares disease-specific quality-of-life, clinical and radiographic outcomes 10-yrs following ACL reconstruction with patellar tendon, single-bundle quadruple-stranded hamstring, or double-bundle hamstring tendon constructs.
Methods
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.
Patient-reported, clinical and radiographic outcomes were assessed at Baseline, 2-, 5- and 10-years post-operatively. The primary outcome was the patient-reported ACL Quality-of-Life (ACL-QOL) score. Secondary outcomes included: pivot shift, kneeling pain, International Knee Documentation Committee (IKDC) Objective scores, Tegner Activity Level, and Single-Leg Hop test. Medial, lateral and patellofemoral compartments were graded (blinded assessor), using the IKDC radiographic scale; categorized as Absence (A/B) or Presence (C/D) of osteoarthritis (OA). Proportions of traumatic re-injuries (complete and partial re-ruptures), and contralateral tears were compared. An analysis of variance for repeated measures, with 95% Confidence Intervals (95%CI) was used for continuous data, and Chi-square analyses for categorical data, with 5% significance level for all analyses.
Results
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 increased over time for all groups (p<0.001), with no difference at 10-years (p=0.912; 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)). Fewer traumatic re-injuries (combined complete and partial graft re-ruptures) occurred with PT grafts (PT: 8%; HT: 23%; DB: 21%, p=0.023). Proportions of contralateral ACL tears were not different (PT: 13%; HT: 13%; DB; 10%; p=0.801). None of the remaining 10-year secondary outcomes were statistically different between groups. Pivot shift grade ≥2 was less likely with a PT reconstruction (PT: 18%; HT: 25%; DB: 24%; p=0.584), with no differences in kneeling pain (PT: 6%; HT: 4%; DB: 7%; p=0.637) and Normal/Nearly Normal IKDC Objective scores (PT: 73%; HT: 68%; DB: 72%; p=0.724).
At 10-years, 44.8% of patients had radiographic OA in at least one knee compartment (medial 17%; lateral 29%; patellofemoral 6.4%). The ACL graft did not show differences in patients with medial OA (PT: 14%, HT: 12%, DB 24%, p=0.094) or patellofemoral OA (PT: 5%, HT: 7%, DB 8%, p=0.782); but statistically significantly more lateral radiographic OA in the PT group (PT: 42%, HT: 23%, DB: 23%; p=0.010). 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 of 10.2±3.5 (p=0.004) and 7.2±2.9 (p=0.010), respectively).
Conclusions
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. There were more traumatic re-injuries and higher-grade pivot shift tests in the HT and DB groups compared to PT reconstructions. However, patients with PT reconstructions were more likely to have radiographic changes in the lateral compartment. ACL reconstruction improves patient's quality-of-life long-term.