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

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 aimed 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 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. Results A consecutive cohort of 69 cases receiving the anchor of interest was included for analysis. Complications were recorded in six cases (8.7%, 95%CI 3.6 - 18.6), 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 43 (IQR 34-52) preoperatively to 9 (IQR 5-23) at 12 months. WORC Index scores improved from 49 (IQR 27-61) preoperatively to 86 (IQR 57-93) at 12 months. Conclusion 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. ### Competing Interest Statement The investigators disclose a funding arrangement with Johnson & Johnson Medical Pty Ltd for EBM Analytics to manage data custodianship of a clinical outcomes registry, and for assistance with running and documentation of this study. Johnson & Johnson Medical Pty Ltd did not provide staff, materials or facilities under this arrangement, and do not have access to the registry database or any identifying information from it. Industry sponsors had no role in the design, collection, management, analysis or interpretation of the data or writing of the manuscript. A copy of the manuscript was provided to Johnson & Johnson Medical Pty Ltd prior to submission for peer-review, but the sponsor had no role in the decision to submit. ### Clinical Protocols ### Funding Statement The investigators disclose a funding arrangement with DePuy Mitek (Johnson & Johnson Medical Pty Ltd) for EBM Analytics to manage data custodianship of a clinical outcomes registry, and for assistance with running and documentation of this study. Johnson & Johnson Medical Pty Ltd did not provide staff, materials or facilities under this arrangement, do not have access to the registry database or any identifying information from it. Industry sponsors had no role in the design, collection, management, analysis or interpretation of the data or writing of the manuscript. A copy of the manuscript was provided to Johnson & Johnson Medical Pty Ltd prior to submission for peer-review, but the sponsor had no role in the decision to submit. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Ethical approval for the study was obtained from the Barwon Health Research Ethics Committee I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors