A Randomized Controlled Trial of PEEK Versus Titanium Interference Screws for Anterior Cruciate Ligament Reconstruction With 2-Year Follow-up.

BACKGROUND: Graft fixation with interference screws for anterior cruciate ligament (ACL) reconstruction is a highly successful technique. Polyether ether ketone (PEEK) is a novel thermoplastic polymer with high biocompatibility and mechanical properties that mimic native bone, and it can be imaged on computed tomography or magnetic resonance imaging (MRI) without signal flare. PURPOSE: To compare the clinical performance of ACL reconstruction with PEEK and titanium interference screws at 2 years and to evaluate a novel method of measuring tunnel volume. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 133 patients underwent arthroscopic ACL reconstruction with 4-strand hamstring autografts and were randomized to have titanium or PEEK interference screws for femoral and tibial tunnel fixation. At 2 years, subjective Lysholm and International Knee Documentation Committee scores were assessed and clinical examination performed. At 12 months, MRI was performed to assess graft incorporation and cyst formation, and a novel technique was employed to measure tunnel volumes. RESULTS: There were no significant differences in graft rerupture rate, contralateral ACL rupture rate, subjective outcomes, or objective outcomes. In the titanium and PEEK groups, MRI demonstrated high overall rates of graft integration (96%-100% and 90%-93%, respectively) and ligamentization (89% and 84%) and low rates of synovitis (22% and 10%) and cyst formation (0%-18% and 13%-15%). There was a higher proportion of patients with incomplete graft integration within the femoral tunnel in the PEEK group as compared with the titanium group (10% vs 0%, P = .03); however, the authors suggest that metal artifact precluded proper assessment of the graft in the titanium group by MRI. Tunnel volumes also appeared to be equivalent in the 2 groups and were measured with a novel technique that was highly reproducible in the PEEK group secondary to the absence of flare. CONCLUSION: Two-year clinical analysis of PEEK interference screws for femoral and tibial fixation of ACL reconstructions showed equivalent clinical performance to titanium interference screws. Given the excellent mechanical characteristics, biological compatibility, and absence of metal artifact on MRI, PEEK has become our material of choice for interference screw fixation in ACL reconstruction.