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A non-inferiority study of two types of PEEK interface screws and EndoButton for anterior cruciate ligament reconstruction under arthroscopy |
LI Guanbo, GAO Peng, CHEN Xintong, WANG Jing |
The Department of Joint and Sports Medicine, The First Affiliated Hospital of Hunan Normal University/Hunan Provincial People's Hospital, Changsha 410005, China |
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Abstract Objective To evaluate the clinical efficacy of Delta Medical's PEEK (polyether ether ketone) interface screws and EndoButton compared to Smith & Nephew's PEEK interface screws and EndoButton in patients undergoing arthroscopic anterior cruciate ligament (ACL) reconstruction. Methods Sixteen patients with ACL injury who underwent arthroscopic ACL reconstruction at Hunan Provincial People's Hospital (the First Affiliated Hospital of Hunan Normal University) between November 2017 and July 2019 were randomly assigned to two groups of 8 patients each. The observation group used Delta Medical's PEEK interface screws and EndoButton, while the control group used Smith & Nephew's PEEK interface screws and EndoButton. The patients were evaluated before and after surgery for Lysholm knee joint score, clinical efficacy rate, laxity, activity, MRI examination results, and incidence of complications. Results The knee joint function scores improved significantly in both groups after surgery. No differences were observed in functional scores, clinical efficacy rates, laxity, and activity. There were no major intraoperative or postoperative complications, such as infection, vascular or nerve injury. Conclusion The knee joint function scores improved after anterior cruciate ligament reconstruction in both groups. There was no significant difference in functional scores and activity between the two groups. Compared with Smith & Nephew, Delta Medical's PEEK interface screws and EndoButton demonstrated non-inferiority. Delta Medical's PEEK interface screws and EndoButton are suitable for arthroscopic anterior cruciate ligament reconstruction.
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Received: 25 March 2023
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