Background: Despite technical and material improvements in rotator cuff repair, clinical and radiological failure remains common. Following suture fixation, tension and footprint compression decrease from time zero. A novel suture has been designed to shorten when submerged in liquid to maintain tension and increase repair construct security. The aim of this study was to assess the safety and clinical outcomes (IDEAL 2a assessment) in patients receiving rotator cuff repair with the self-tensioning suture with a minimum of 12 months follow up. Clinical registries allow early identification of outlier or poorly performing prosthesis with prevention of avoidable complications.
Methods: A cohort analysis was performed utilizing patients from the PRULO (Patient Reported Outcomes in Upper Limb Surgery) registry. All patients with the suture of interest who underwent a rotator cuff repair with 12 months follow up were included. Results included patient reported outcome scores: Quick Disability of the Arm, Shoulder and Hand (QuickDASH), and the Western Ontario Rotator Cuff Index (WORC) and complications. Patient reported outcome measures (PROMs) were analyzed using multiple imputation and a linear model to assess changes over 12 months follow up.
Results: A cohort of 255 patients was included for analysis. At 12 months follow up, median scores for QuickDASH decreased by 36 and WORC increased by 41, both of which surpass the minimum clinically important difference. Our observed rates of complications included: Infection 2.4%, stiffness/capsulitis 13%, and retear 12%. Complication rates and functional improvements were similar to other studies. These results suggest the suture is safe and adequately effective for ongoing clinical use and further study.
Conclusion: The novel suture demonstrated comparable safety and efficacy profiles, with outcomes similar to those published in the literature. This study suggests this novel suture is safe and does not seem to produce unique complications. Further research is warranted to specifically investigate clinical efficacy in the longer term.
Trial Registration: ACTRN12619000770167
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