A Randomized Clinical Trial Comparing Patellar Tendon, Hamstring Tendon, and Double-Bundle ACL Reconstructions: Patient-Reported and Clinical Outcomes at 5-Year Follow-up.

BACKGROUND: This randomized clinical trial evaluated the 5-year, disease-specific quality-of-life outcomes of patients treated for anterior cruciate ligament (ACL) deficiency with use of a patellar tendon, single-bundle quadruple-stranded hamstring, or double-bundle hamstring reconstruction.
METHODS: Patients (n = 110 per group; 183 male; 14 to 50 years of age) were randomly allocated to anatomically positioned ACL reconstruction with use of a patellar tendon graft (patellar tendon group; mean age, 28.7 years), quadruple-stranded hamstring tendon construct (hamstring tendon group; mean age, 28.5 years), or double-bundle hamstring tendon construct (double-bundle group; mean age, 28.3 years). Computer-generated allocation with varied block randomization was performed intraoperatively. The 5-year primary outcome measure was the Anterior Cruciate Ligament-Quality of Life (ACL-QOL) score, and secondary outcome measures included the International Knee Documentation Committee (IKDC) subjective score and objective grades, pivot shift assessment, range of motion, kneeling pain, Tegner activity scale, Cincinnati Occupational Rating Scale, complete traumatic reruptures, partial traumatic tears, total traumatic reinjuries, and atraumatic graft failures.
RESULTS: Three hundred and fifteen patients (95%) completed the 5-year follow-up (4 withdrawals, and 11 lost to follow-up). ACL-QOL scores increased significantly from baseline for all groups (p < 0.0001), but mean scores at 5 years did not differ among the groups (p = 0.548): mean (and standard deviation) of 82.5 ± 17.9 (95% confidence interval [CI], 79.0 to 86.0) for patellar tendon, 83.9 ± 18.2 (95% CI, 80.3 to 87.4) for hamstring tendon, and 81.1 ± 19.3 (95% CI, 77.4 to 84.8) for double-bundle. The proportions of patients at 5 years with a pivot shift grade of ≥2 (12% for patellar tendon, 16% for hamstring tendon, and 22% for double-bundle; p = 0.149) and with normal and nearly normal knees per IKDC grade (87%, 82%, and 75% for the 3 groups, respectively; p = 0.093) trended in favor of patellar tendon reconstruction. No differences were seen for the IKDC subjective scores, knee range of motion including passive extension deficits, the single leg hop test, Cincinnati Occupational Rating scores, and Tegner activity levels. Kneeling pain was more common with patellar tendon reconstruction (10% of patients compared with 4% for hamstring tendon and 2% for double-bundle; p = 0.029). For hamstring tendon and double-bundle reconstructions, there were trends toward more complete traumatic reruptures (4% for patellar tendon, 10% for hamstring tendon, and 10% for double-bundle; p = 0.145) and partial traumatic tears (0%, 5%, and 6%, respectively; p = 0.059), with significantly fewer combined traumatic reinjuries in the patellar tendon group (4 patients compared with 16 for hamstring tendon and 17 for double-bundle; p = 0.010). Atraumatic graft failure (pivot shift grade of ≥2) was found for 10% of the patients.
CONCLUSIONS: At 5 years, we found no significant difference in the quality-of-life outcome among the patellar tendon, hamstring tendon, and double-bundle techniques for ACL reconstruction. Significantly more patients in the hamstring tendon and double-bundle groups experienced traumatic graft reinjury compared with the patellar tendon group. There was a trend toward a higher percentage with normal and nearly normal IKDC grades in the patellar tendon group compared with hamstring tendon and double-bundle groups. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

RCT Entities:   Population Interventions Outcomes