Anterior Cruciate Ligament (ACL) reconstruction is a well established procedure for restoration of stability following ACL rupture. Several methods exist for fixation of soft tissue grafts on the tibia, without general agreement about the optimal method. This study compared two different methods of tibial fixation using hamstring grafts in ACL reconstruction.

113 consecutive patients were randomized into two groups at the time of surgery. In group one, fixation was with a metal interference screw (RCI) and staples and in group two, with a polyethylene screw and sheath (Intrafix). Evaluation of outcomes was conducted using KT-1000 arthrometer, Lysholm, IKDC subjective and Mohtadi scores.

7 reinjuries occurred within the time frame of the study, mostly related to sporting injuries, with 5 in group 2. 81% of remaining participants were successfully followed at 2 years post surgery. No significant difference in mean KT-1000 side-to-side measurements was found between groups at an average follow-up of 30 months (1.5 ± 1.9mm and 1.8 ± 1.9mm, respectively; p > 0.05). The mean Lysholm score for group one was 65.2 ± 15.5 preoperatively and 90.8 ± 9.5 postoperatively; for group two these scores were 62.0 ± 20.7 preoperatively and 88.8 ± 14.3 postoperatively. This improvement in scores after surgery was similar for both groups and was not significantly different between groups (p > 0.05). Both the IKDC subjective and Mohtadi scores showed significant (p < 0.05) improvements postoperatively compared with pre-operatively but no significant difference between fixation groups.

There were no significant differences between the two groups for any outcome value, with both methods of graft fixation producing good results. The newer Intra-fix device had a higher reinjury rate but this was not significantly different from the screw and staple fixation, and on all other outcome measures the Intrafix device was equivalent to an interference screw and staples for tibial-sided graft fixation in ACL reconstruction.