Experimental mechanical and histologic evaluation of the Kennedy ligament augmentation device.

Reconstruction of the knee with a chronic injury to the anterior cruciate ligament is an unsolved problem. Biologic graft substitutes have failed to maintain knee stability in the longer postreconstruction intervals. In an attempt to overcome the limitations in graft performance, synthetic materials have been proposed to augment the biologic tissue. In this study, a 6-mm polypropylene braid Ligament Augmentation Device (LAD) possessing a tensile strength of 1500 N and excellent fatigue and creep properties was investigated as an adjunct to the MacIntosh/Marshall Over-the-Top repair. A two-year animal study of 54 adult goats was conducted in which experimental ACL defects were created and reconstructed with a transplant consisting of a portion of the rectus femoris tendon, prepatellar tissue, and the central one-third of the patellar tendon. The goats were equally divided between nonaugmented and LAD-augmented groups and sacrificed at three, six, 12, and 24 months after surgery. Mechanically, the augmented transplants were substantially stronger at the time of initial implantation (364N versus 26N) and again at two years (841N versus 528N). Intermediate times did not demonstrate a difference in strength. Histologically, the augmented transplants consisted of a loosely organized fibrous capsule surrounding the LAD. At 24 months, "insertion fibers" were noted to provide continuity between the fibrous tissue and bone on both the tibia and femur.