Prospective randomized clinical comparison of femoral transfixation versus bioscrew fixation in hamstring tendon ACL reconstruction--a preliminary report.

The purpose of this study is to clinically evaluate hamstring tendon anterior cruciate ligament (ACL)-reconstruction using femoral fixation with bioresorbable interference screws and with a bioresorbable transfixation device. The ACL-reconstruction using the transfixation device at the femoral side leads to less knee laxity and therefore to a better clinical outcome for the patient. Prospective randomized clinical outcome study. From February 2002 to December 2002, a total of 68 patients with hamstring ACL reconstruction using a femoral fixation once with TransFix (n=38; m:22 and f:16; median age=28.5 range 15–47) and the second with bioscrew (BS) (n=30; m:20, f:10; median age=25.5 range 13–61) completed the follow-up period. Patients in each group got a clinical assessment at 3, 6, and 12 months after surgery. The measurement of anterior translation of the tibia has been performed using the Rolimeter® device. No significant differences in the knee laxity testing using the Rolimeter device were seen between both groups and over time within these groups. Ninety percent of all patients had functionally normal or near normal International Knee Documentation Committee (IKDC) knee ligament ratings. The TF-group included 17 grade A, 19 grade B, and 2 grade C knees, and the BS-group had 12 grade A, 13 grade B, and 5 grade C knees. The IKDC rating, the OAK-score, the Tegner-activity-score, and the Lysholm-score did not show significant differences between the TF-group and the BS-group. We disproved our hypothesis that the transfixation technique leads to less laxity and therefore to a better clinical outcome when compared to the use of BS. The clinical results in this study clarified that this technique is an effective and safe method for femoral hamstring fixation in ACL-reconstruction. However, this technique revealed no advantage compared to the bioscrew fixation technique within the short-term follow-up.