Background: Despite technical and material improvements in rotator cuff repair (RCR) clinical and radiological failure remains common. Following suture fixation, tension and footprint compression decrease from time zero. A novel suture (Dynacord, Depuy Synthes) has been designed to shorten when submerged in liquid to maintain tension and increase repair construct security. Methods: A retrospective cohort analysis was performed on the PRULO (Patient Reported Outcomes in Upper Limb Surgery) registry for 12 months follow up after RCR using this suture regarding all cause failure, rates of common complications, Quick Disability of the Arm, Shoulder and Hand (QuickDASH), and Western Ontario Rotator Cuff Index (WORC). Summary statistics were generated for patient characteristics and patient-reported outcome measures (PROMs) analysed using multiple imputation and a linear model to assess changes over 12 months follow up. Results: A cohort of 236 cases was included for analysis. Complication rates and functional improvements were comparable to literature on similar sutures. At 12 months follow up, all-cause failure occurred in 12% of cases, and mean scores for QuickDASH decreased by 37 and WORC increased by 44, both of which surpass the minimum clinically important difference. Our observed rates of complications are as follows: Infection 2.1%, stiffness/capsulitis 11% and retear 12%. Conclusion: The novel suture demonstrated favourable safety and efficacy profiles, with outcomes comparable to those published for commonly used sutures. This study through an IDEAL 2a framework for surgical innovation highlights this suture as safe, effective in mitigating common failure mechanisms and having satisfactory outcomes in RCR.

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.

https://academic.oup.com/jsprm/article/2023/4/snad014/7317733

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.

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

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Yes

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Yes

All data produced in the present study are available upon reasonable request to the authors