START:REACTS team (Including:
). (2023) Subacromial spacer for Tears Affecting Rotator cuff Tendons : a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS). Efficacy and Mechanism Evaluation, 10 (3). doi:10.3310/TKJY2101 ISSN 2050-4365.Preview |
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Abstract
Background
A balloon spacer is a relatively simple addition to an arthroscopic debridement procedure for irreparable rotator cuff tears.
Objective
To evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.
Design
A multicentre participant-and assessor-blinded randomised controlled trial comparing arthroscopic debridement with the InSpace® (Stryker, Kalamazoo, MI, USA) balloon to arthroscopic debridement alone, using a novel adaptive design. Pretrial simulations informed stopping boundaries for two interim analyses, using outcome data from early and late time points.
| Item Type: | Journal Article |
|---|---|
| Subjects: | R Medicine > RD Surgery |
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School Faculty of Science, Engineering and Medicine > Engineering > WMG (Formerly the Warwick Manufacturing Group) |
| Library of Congress Subject Headings (LCSH): | Shoulder joint -- Rotator cuff -- Evaluation, Shoulder joint -- Rotator cuff -- Surgery -- Evaluation, Tendons -- Transplantation, Clinical trials |
| Journal or Publication Title: | Efficacy and Mechanism Evaluation |
| Publisher: | NIHR Health Technology Assessment Programme |
| ISSN: | 2050-4365 |
| Official Date: | 31 August 2023 |
| Dates: | Date Event 31 August 2023 Published 15 March 2023 Accepted |
| Volume: | 10 |
| Number: | 3 |
| DOI: | 10.3310/TKJY2101 |
| Status: | Peer Reviewed |
| Publication Status: | Published |
| Access rights to Published version: | Open Access (Creative Commons open licence) |
| Date of first compliant deposit: | 22 September 2023 |
| Date of first compliant Open Access: | 25 September 2023 |
| RIOXX Funder/Project Grant: | Project/Grant ID RIOXX Funder Name Funder ID 16/61/18 [NIHR] National Institute for Health Research. Efficacy and Mechanism Evaluation UNSPECIFIED |
| Related URLs: | |
| URI: | https://wrap.warwick.ac.uk/179529/ |
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