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.
Abstract Background: 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. As there were no statistically or clinically relevant differences in the results two years postoperatively, we hypothesize that after five years of follow-up there is no difference in the outcome after either cross-pin or absorbable interference screw fixation in ACL (anterior cruciate ligament) reconstruction with hamstring tendon autografts.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. There was a significant difference in additional procedures between the 2 and 5 years follow-up, group I had six additional procedures between the 2 and 5 years follow-up (P=.041). Conclusion: There was a statistically significant difference in the additional procedures, most in group I (six). None of these procedures found problems with the ACL graft. 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.