A prospective comparison of 3 hamstring ACL fixation devices--Rigidfix, BioScrew, and Intrafix--randomized into 4 groups with 2 years of follow-up.

Background: New devices for graft fixation in anterior cruciate ligament reconstruction are released to clinical use without clinical follow-up data.

Hypothesis: There is similar clinical outcome after either cross-pin or absorbable interference screw fixation in anterior cruciate ligament reconstruction with hamstring tendons.

Study Design: Randomized controlled clinical trial; Level of evidence, 1.

Methods: A total of 120 patients were randomized into 4 different groups (30 each) for anterior cruciate ligament reconstruction with hamstring tendons: femoral Rigidfix cross-pin and Intrafix tibial expansion sheath with a tapered expansion screw; Rigidfix femoral and BioScrew interference screw tibial fixation, BioScrew femoral and Intrafix tibial fixation; or BioScrew fixation into both tunnels. The evaluation methods were clinical examination, knee scores, and instrumented laxity measurements.

Results: Ten patients were completely lost to follow-up and 3 revisions were done before the 2-year follow-up, leaving 107 of 120 (89%) patients for analysis. No statistically significant differences between the groups were seen 2 years postoperatively, and all but 2 patients in the Rigidfix/Intrafix and Rigidfix/BioScrew groups, respectively, were classified into International Knee Documentation Committee A or B categories. A revision reconstruction was performed before the 2-year follow-up in 2 cases after a high-energy injury caused a rerupture (1 in Rigidfix/Intrafix and 1 in BioScrew/BioScrew groups). In addition, there were 4 nontraumatic failures revised before the 2-year follow-up (2 in Rigidfix/Intrafix and 1 each in Rigidfix/BioScrew and BioScrew/BioScrew).

Conclusion: There were no statistically or clinically relevant differences in the results 2 years postoperatively, and all 4 techniques improved patient performance.