Purpose: Hamstring tendon grafts are commonly used in anterior cruciate ligament (ACL) reconstructions. A number of fixation devices are available; however, several have limited clinical support. To our knowledge, no randomized controlled study comparing the EZLoc and the Bone Mulch Screw for femoral fixation in ACL reconstruction exists. Therefore, the purpose of this study was to compare the results following the use of these two femoral fixation devices. Time in surgery for the two methods was also to be compared.
Methods: A total of 110 patients between 18 and 45 years old at two orthopaedic departments, A (n = 55) and B (n = 55), were randomized to ACL reconstruction with femoral fixation of the hamstring graft with either the EZLoc or the Bone Mulch Screw. Surgical time was measured for each group. The patients were evaluated after 6 weeks and 3, 6, 12 and 24 months. The clinical examination included range of motion, evaluation of intraarticular swelling, tenderness at the lateral femoral condyle, the Lachman test, the Pivot shift test and the KT-1000 arthrometer. In addition, the visual analogue scale score for pain, the Tegner activity score, the Lysholm functional score and the knee injury and osteoarthritis outcome score were recorded. Knee extension and flexion muscle strength were also measured with a Biodex.
Results: There were no significant differences in any of the parameters mentioned above at the 2-year follow-up evaluation. Three patients in each group underwent revision ACL reconstruction during the study. More than 95% of the knees in both groups were found to be stable. Good to excellent results were found for all selected knee scores in both groups. There were no statistically significant differences between the two groups in any of the muscle strength parameters. Time in surgery was statistically significantly shorter in the EZLoc group compared with the Bone Mulch group.
Conclusion: There were no statistically significant differences in clinical findings, knee scores or in muscle strength between the EZLoc group and the Bone Mulch group at the 2-year follow-up evaluation. Time in surgery was statistically significantly shorter for patients undergoing ACL reconstruction with hamstring grafts when the EZLoc femoral fixation device was used.
Level of evidence: II.