Stage 2a IDEAL evaluation of a third-generation biocomposite suture anchor in arthroscopic rotator cuff repair: Subgroup cohort analysis of the PRULO registry with 12-month follow up

BackgroundPoly-lactic co-glycolide with tricalcium phosphate (PLGA)/{beta}-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. MethodsA sub-group analysis of a prospective clinical registry embedded in an orthopaedic clinic was conducted. Patients undergoing surgery with the Healix Advance BR were identified and data on patient demographics, treatment details, complications and adverse events, as well as patient-reported outcomes (QuickDASH, WORC Index Normalised) were retrieved. Summary statistics were generated for patient characteristics and PROMs analysed using multiple imputation and a linear model to assess changes between baseline and 12 month follow up. ResultsA 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 QuickDASH scores improved significantly from 45 (IQR 34-57) preoperatively to 5 (IQR 2-22) at 12 months. WORC Index scores improved from 46 (IQR 27-60) preoperatively to 85 (IQR 62-93) at 12 months. ConclusionThis 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.