Randomized comparative study of suspension femoral fixation device in graft position maintenance in anterior cruciate ligament reconstruction: EndoButton CL vs TightRope RT.

研究概要

Thirty patients undergoing an arthroscopic double-bundle anterior cruciate ligament reconstruction were randomized in this non-inferiority trial to receive an EndoButton CL (n=15) or TIghtRope RT (n=15) device for graft fixation on the femoral side. The primary outcome of interest was graft elongation at 6 months. Secondary outcomes of interest included the single leg hop test index, anterior translation of the tibia, Lachman test and lateral pivot shift test, and Lysholm score. Graft elongation was assessed at 3, 6 and 12 months, and secondary outcomes were assessed 12 months post-operation. Results revealed no significant differences in all outcomes between the two groups, at all time-points. However, the non-inferiority margin of -1.5mm for graft elongation was not reached.