2017 ISAKOS Biennial Congress Paper #206

 

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

Nick Mohtadi, MD, MSc, FRCSC, Calgary, AB CANADA
Denise S. Chan, MBT, MSc, Calgary, AB CANADA
Rhamona Barber, BKin, CAT(C), Calgary, AB CANADA

University of Calgary Sport Medicine Centre, Calgary, Alberta, CANADA

FDA Status Not Applicable

Summary

This is the largest clinical trial in ACL surgery with 95% follow-up. At 5-years, no difference in disease-specific Q of L, between: patellar tendon (PT), hamstring (HT) and double-bundle hamstring (DB) reconstructions. 11.1% suffered a traumatic graft injury, higher in the HT and DB groups; 8.9% of patients required a repeat arthroscopy and 8.9% suffered a contralateral ACL rupture.

Abstract

Purpose

To compare anterior cruciate ligament reconstruction using patellar tendon (PT), quadruple hamstring tendons (HT) and the double-bundle hamstring tendons (DB) graft options, by measuring patient-reported disease-specific quality of life outcome in patients with isolated ACL deficiency of the knee at a minimum five-years post-operative follow-up.

Methods

In this prospective double-blind randomized clinical trial, 330 patients (183 males, 147 females) aged 14-50 years were randomly allocated and equally distributed to one of three ACL autograft reconstruction techniques: 1) Anatomic Patellar Tendon (PT; mean age 28.7 years), 2) Anatomic Quadruple-stranded Hamstring Tendon (HT; mean age 28.5 years), or 3) Anatomic Double-Bundle using hamstring tendons (DB; mean age 28.3 years).
Outcomes were measured pre-operatively at baseline, and post-operatively at 3 and 6 months, 1, 2 and 5 years. The 2-year results have been previously published. The primary outcome was the Anterior Cruciate Ligament Quality-of-Life (ACL-QOL) measure. Secondary outcomes included the International Knee Documentation Committee (IKDC) subjective score and objective grades, pivot shift, Tegner score, the Cincinnati Occupational Rating Scale, and re-injuries. Radiographic evaluation was performed at baseline, 2 and 5 years; this analysis is ongoing.

Results

315 randomized patients (95%) completed a minimum five-year follow-up. There was no difference in any baseline characteristics. There were no differences in mean ACL-QOL score at five-years (p=0.548): PT = 82.9 (SD 17.4, 95% CI 79.5 – 86.3); HT = 83.7 (SD 18.4, 95% CI 80.1 – 87.3); DB = 81.8 (SD 18.6, 95% CI 78.2 – 85.4); in the proportion of patients with a Pivot Shift grade 2 or greater (p=0.573): PT = 11/103 (14%); HT = 16/105 (18%); DB = 20/107 (19%); mean IKDC subjective scores between groups (p=0.770): PT = 83.9 (SD = 12.9, 95% CI = 81.4 – 86.5); HT = 85.2 (SD = 13.0, 95% CI = 82.7 – 87.7); DB = 84.3 (SD = 13.4, 95% CI = 81.7 – 86.9), and IKDC objective grades Normal/Nearly Normal knees PT = 85/98 (87%); HT = 82/99 (81%); DB = 75/103 (76%), p=0.093. Tegner activity levels and Cincinnati Occupational Scores were not statistically different between the groups (p=0.874 and p=0.813, respectively).

The frequency of complete traumatic graft ruptures was higher in the Hamstring and Double Bundle groups (PT = 4/103; HT = 11/105; DB =11/107; p=0.145). Revision ACL reconstructions were performed on 22/26 of these patients. There were an additional 11 partial graft re-ruptures (PT=0; HT=5; DB=6) with the total re-injuries much less in the patellar tendon group (Total re-injuries: PT=4; HT=16 and DB=17 p=0.010).
Twenty-nine additional arthroscopic procedures were required in 28 patients (9.2%) PT=7, HT=10, DB=11. Contra-lateral ACL ruptures occurred in 28 patients (8.9%). Kneeling pain remained more common the PT group (PT=10/98; HT 4/98; DB 2/91; p=0.029).

Conclusions

At five-years there was no difference in disease-specific quality-of-life outcome or IKDC grades between the PT, HT and DB techniques for ACL reconstruction. There were significantly more traumatic re-injuries in the HT and DB groups compared to the PT group. Contralateral ACL tears and repeat surgery, increased form the 2-year follow-up.