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Subacromial spacer for Tears Affecting Rotator cuff Tendons : a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)
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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.
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WRAP-Subacromial-spacers-adults-symptomatic-rotator-cuff-tears-RCT-23.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (5Mb) | Preview |
Official URL: https://doi.org/10.3310/TKJY2101
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 | ||||||||||||
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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) |
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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: |
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Volume: | 10 | ||||||||||||
Number: | 3 | ||||||||||||
DOI: | 10.3310/TKJY2101 | ||||||||||||
Status: | Peer Reviewed | ||||||||||||
Publication Status: | Published | ||||||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||||||
Date of first compliant deposit: | 22 September 2023 | ||||||||||||
Date of first compliant Open Access: | 25 September 2023 | ||||||||||||
RIOXX Funder/Project Grant: |
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