A prospective comparison of 3 hamstring ACL fixation devices—rigidfix, bioscrew, and intrafix—randomized into 4 groups with a minimum follow-up of 5 years

BACKGROUND: ACL (anterior cruciate ligament) reconstruction remains the gold standard surgical option for patients with ACL tears. There are many fixation devices available for ACL reconstruction. Recent ACL reconstruction strategies are aiming to reproduce the native anatomy and normal kinematics of the knee. This is a five years follow-up report of some of the new devices for graft fixation. A two years follow-up data was published previously. METHODS: 120 patients were randomized into four different groups (30 each) for ACL reconstruction with hamstring tendons: group I femoral Rigidfix cross-pin and Intrafix tibial extension sheath with a tapered expansion screw; group II Rigidfix femoral and BioScrew interference screw tibial fixation; group III BioScrew femoral and Intrafix tibial fixation; group IV BioScrew fixation into both tunnels. The evaluation methods were clinical examination, knee scores, and instrumented laxity measurements. RESULTS: In this 5 years follow-up there were 102/120 (85%) patients available, but only 77 (64,2%) attended the clinical examinations. No significant difference between the groups in the clinical results was detected. Between the 2 and 5 years follow-up there were 6 additional procedures in group I and one in group II. There was a significant difference in additional procedures between group I and the other groups (P = .041). CONCLUSION: There was a statistically significant difference in the additional procedures, most in group I (six). The ACL grafts were intact. Other statistically or clinically significant differences in the 5 years follow-up results were not found. STUDY DESIGN: Randomized controlled clinical trial; Level of evidence, 1. Trial registration ISRCTN registry with study ID ISRCTN34011837. Retrospectively registered 17.4.2020.