Low incidence of adverse events or construct failure of a novel high-strength No.2 round suture in rotator cuff repair: An IDEAL Stage 2a assessment retrospective cohort analysis

Abstract

BackgroundDespite 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.MethodsA 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.ResultsA 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%.ConclusionThe 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.