Reconstruction of acute anterior cruciate ligament injuries: a prospective, randomised study of 40 patients with 7-year follow-up. No advantage of synthetic augmentation compared to a traditional patellar tendon graft.

摘要

BACKGROUND: In a prospective, randomised study, we compared the results of anterior cruciate ligament reconstruction using the conventional medial patellar tendon strip procedure with the Kennedy ligament augmentation device (LAD) over-the-top augmentation technique. The aim of the study was to see if the addition of this device, with its specific potential complications (infection, synovitis, mechanical failure) and increased costs, gave better functional stability and less donor site morbidity. METHODS: Forty patients ( n=20+20) with high physical demands, anterior cruciate ligament rupture less than 3 weeks old, and positive Lachman and pivot shift tests were included in the study. They were randomised by instructions in a sealed envelope that was randomly chosen. Postoperatively, they were immobilised in a plaster of Paris cast for 2 weeks. Full weight-bearing was not allowed until 6 weeks after the operation. Strength training on the operated side started when movement was restored to nearly normal, usually after 8-10 weeks. Return to full sport activity was allowed 1 year after the operation. Clinical and arthrometric follow-up was performed yearly using the Lysholm functional score, Tegner activity score, KT-1000 testing, Lachman and pivot shift tests. Follow-up lasted 3-9 years (mean 7 years). RESULTS AND CONCLUSIONS: At last follow-up we found no statistical difference in stability tests, functional or activity scores; both groups showed stable improvement concerning scores and arthrometry compared with the preoperative values. No advantages were associated with the use of the Kennedy LAD, and we do not recommend it or a similar device for uncomplicated cases. New augmentation devices are simply launched onto the market, and we recommend caution and thorough evaluation in prospective, randomised studies before they are adopted into use.