A pilot randomised controlled trial assessing standard versus dermal patch-augmented rotator cuff repair found no adverse effects and suggest future trials need a minimum of 150 patients

Snow, Martyn; Kuiper, Jan Herman; James, Steven; Keeling, Ellie; Rich, Sophie; Amit, Priyadarshi

Abstract

The aims of this pilot randomised controlled trial (RCT) were to assess the safety and efficacy of a human dermal allograft patch and assess the feasibility of a future RCT comparing retear rate and functional outcome 12 months following standard and augmented double-row rotator cuff repair.

Citation

Snow, M., Kuiper, J. H., James, S., Keeling, E., Rich, S., & Amit, P. (in press). A pilot randomised controlled trial assessing standard versus dermal patch-augmented rotator cuff repair found no adverse effects and suggest future trials need a minimum of 150 patients. Knee Surgery, Sports Traumatology, Arthroscopy, https://doi.org/10.1007/s00167-023-07356-5

• Journal Article Type: Article
• Acceptance Date: Feb 20, 2023
• Online Publication Date: Mar 2, 2023
• Deposit Date: Jun 1, 2023
• Journal: Knee Surgery, Sports Traumatology, Arthroscopy
• Print ISSN: 0942-2056
• Electronic ISSN: 1433-7347
• Publisher: Springer Verlag
• Peer Reviewed: Peer Reviewed
• DOI: https://doi.org/10.1007/s00167-023-07356-5
• Keywords: Orthopedics and Sports Medicine; Surgery
• Additional Information: Received: 25 August 2022; Accepted: 20 February 2023; First Online: 2 March 2023; : ; : None of the authors had any conflict of interest.; : Ethical approval was obtained from institute ethics committee (REC reference 12/WM/0127).; : Informed consent was obtained from all the patients before enrolment into the study.