Abstract
BACKGROUND: Poly-lactic co-glycolide with tricalcium phosphate (PLGA)/β-TCP is both bioactive and biodegradable, and is considered a third generation biomaterial for suture anchors. This study aims to describe the incidence of adverse events and the trajectory of patient-reported outcomes up to 12 months follow up in patients undergoing rotator cuff repair with this type of anchor. METHODS: A sub-group analysis of a prospective registry of a regional private clinic embedded in an orthopaedic clinic was conducted. This study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12619000770167) with date 23/05/2019. Patients undergoing surgery from Jun-2020 to Mar-2024 with the Healix Advance BR were identified and data on patient demographics, treatment details, complications and adverse events, as well as patient-reported outcome measures (PROMs) were retrieved. Summary statistics were generated for patient characteristics and PROMs analysed using multiple imputation and mixed-effects linear models to assess changes between baseline and 12 month follow up. RESULTS: A consecutive cohort of 68 cases receiving the anchor of interest was included for analysis. Complications were recorded in six cases (8.8%, 95%CI 3.6-18.9), presenting as postoperative capsulitis/stiffness (N = 3), persistent shoulder pain (N = 1), a case of hemi-diaphragm palsy and a case of complex regional pain syndrome in the hand. No infections or reoperations were encountered in this series. The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) scores improved significantly from 42 (IQR 32-52) preoperatively to 5 (IQR 2-14) at 12 months. Western Ontario Rotator Cuff (WORC Index) scores improved from 35 (IQR 21-54) preoperatively to 88 (IQR 70-95) at 12 months. CONCLUSIONS: This study found a low incidence of adverse events, no requirement for reoperation or revision, and favourable recovery of patient-reported outcomes in patients treated with arthroscopic rotator cuff repair with a third-generation biocomposite suture anchor at up to 12 months follow up. TRIAL REGISTRATION: Ethics approval for the Patient Registry of Upper Limb Pathology Outcomes (PRULO) has been provided by the Human Research Ethics Committee at Barwon Health (Project ID 49184, Reference 19/70). This study is registered on the Australian New Zealand Clinical Trials Registry (ACTRN12619000770167) with date 23/05/2019.