Yuval Arama1, Lucy J Salmon1, Kesavan Sri-Ram1, James Linklater2, Justin P Roe3, Leo A Pinczewski4. 1. North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia. 2. Castlereagh Imaging, Sydney, Australia. 3. North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia The Mater Hospital, Sydney, Australia. 4. North Sydney Orthopaedic and Sports Medicine Centre, Sydney, Australia The Mater Hospital, Sydney, Australia Notre Dame University, Sydney, Australia lpinczewski@nsosmc.com.au.
Abstract
BACKGROUND: Longer-term results of bioabsorbable screws for anterior cruciate ligament reconstruction (ACLR) have been reported, but results are specific to the exact screw material and design. Titanium and poly-L-lactic acid with hydroxyapatite (PLLA-HA) screw outcomes have been compared only to 2 years. PURPOSE/HYPOTHESIS: The purpose of this study was to compare the clinical and radiologic outcomes of the PLLA-HA screw versus titanium screw for hamstring tendon ACLR over a 5-year follow-up period. The hypothesis was that there are no differences in clinical scores or tunnel widening between the PLLA-HA and the titanium screws and that the PLLA-HA screw as seen on magnetic resonance imaging (MRI) should show high-grade resorption and ossification response over 5 years. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 40 patients undergoing ACLR were randomized to receive either a PLLA-HA screw (PLLA-HA group) or a titanium screw (titanium group) for ACL fixation. Blinded evaluation was performed at 2 and 5 years with the International Knee Documentation Committee and Lysholm knee score, KT-1000 arthrometer, single-legged hop test, and MRI to evaluate tunnel and screw volumes, periscrew ossification, graft integration, and cyst formation. RESULTS: There was no difference in any clinical outcome measure at 2- or 5-year follow-up between the 2 groups. At 2 years, the femoral tunnel in the PLLA-HA group was smaller than that in the titanium group (P = .02); at 5 years, there was no difference. At 2 years, the femoral PLLA-HA screw was a mean 76% of its original volume, and by 5 years, it was 36%. At 2 years, the tibial PLLA-HA screw mean volume was 68% of its original volume, and by 5 years, it was 46%. At 5 years in the PLLA-HA group, 88% of femoral tunnels and 56% of tibial tunnels demonstrated a significant ossification response. There was no increase in cyst formation in the PLLA-HA group and no screw breakages. CONCLUSION: There were equivalent clinical results between the PLLA-HA and titanium groups at 2- and 5-year follow-ups. The PLLA-HA screw was not associated with increased tunnel widening or cyst formation when compared with the titanium screw. The PLLA-HA screw demonstrated progressive screw resorption and gradual but incomplete ossification over 5 years.
RCT Entities:
BACKGROUND: Longer-term results of bioabsorbable screws for anterior cruciate ligament reconstruction (ACLR) have been reported, but results are specific to the exact screw material and design. Titanium and poly-L-lactic acid with hydroxyapatite (PLLA-HA) screw outcomes have been compared only to 2 years. PURPOSE/HYPOTHESIS: The purpose of this study was to compare the clinical and radiologic outcomes of the PLLA-HA screw versus titanium screw for hamstring tendon ACLR over a 5-year follow-up period. The hypothesis was that there are no differences in clinical scores or tunnel widening between the PLLA-HA and the titanium screws and that the PLLA-HA screw as seen on magnetic resonance imaging (MRI) should show high-grade resorption and ossification response over 5 years. STUDY DESIGN: Randomized controlled trial; Level of evidence, 1. METHODS: A total of 40 patients undergoing ACLR were randomized to receive either a PLLA-HA screw (PLLA-HA group) or a titanium screw (titanium group) for ACL fixation. Blinded evaluation was performed at 2 and 5 years with the International Knee Documentation Committee and Lysholm knee score, KT-1000 arthrometer, single-legged hop test, and MRI to evaluate tunnel and screw volumes, periscrew ossification, graft integration, and cyst formation. RESULTS: There was no difference in any clinical outcome measure at 2- or 5-year follow-up between the 2 groups. At 2 years, the femoral tunnel in the PLLA-HA group was smaller than that in the titanium group (P = .02); at 5 years, there was no difference. At 2 years, the femoral PLLA-HA screw was a mean 76% of its original volume, and by 5 years, it was 36%. At 2 years, the tibial PLLA-HA screw mean volume was 68% of its original volume, and by 5 years, it was 46%. At 5 years in the PLLA-HA group, 88% of femoral tunnels and 56% of tibial tunnels demonstrated a significant ossification response. There was no increase in cyst formation in the PLLA-HA group and no screw breakages. CONCLUSION: There were equivalent clinical results between the PLLA-HA and titanium groups at 2- and 5-year follow-ups. The PLLA-HA screw was not associated with increased tunnel widening or cyst formation when compared with the titanium screw. The PLLA-HA screw demonstrated progressive screw resorption and gradual but incomplete ossification over 5 years.
Authors: Lindsey M Spragg; Heather A Prentice; Andrew Morris; Tadashi T Funahashi; Gregory B Maletis; Rick P Csintalan Journal: Knee Surg Sports Traumatol Arthrosc Date: 2019-03-01 Impact factor: 4.342
Authors: Pedro Debieux; Carlos E S Franciozi; Mário Lenza; Marcel Jun Tamaoki; Robert A Magnussen; Flávio Faloppa; João Carlos Belloti Journal: Cochrane Database Syst Rev Date: 2016-07-24
Authors: Dennis E Kramer; Leslie A Kalish; Mininder S Kocher; Yi-Meng Yen; Lyle J Micheli; Benton E Heyworth Journal: Orthop J Sports Med Date: 2020-02-26