201 patients undergoing ACL reconstruction with a single-bundle bone-patellar tendon-bone autograft were randomized to either receive or not receive an augmentation device applied to the graft. The purpose was to compare clinical and functional outcome between the two techniques. Follow-up was conducted for 4 years postoperatively, and for 12 years in a subset of patients. The results demonstrated no significant difference between the augmented and nonaugmented graft with respect to knee laxity or clinical scores. By 4 years, 10 of the augmentation devices required removal.