Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)

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Standard

Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons : a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS). / Metcalfe, Andrew; Gemperle Mannion, Elke; Parsons, Helen; Brown, Jaclyn; Parsons, Nicholas; Fox, Josephine; Kearney, Rebecca; Lawrence, Tom; Bush, Howard; McGowan, Kerri; Khan, Iftekhar; Mason, James; Hutchinson, Charles; Gates, Simon; Stallard, Nigel; Underwood, Martin; Drew, Stephen.

In: BMJ open, Vol. 10, No. 5, e036829, 21.05.2020.

Research output: Contribution to journalArticle

Harvard

Metcalfe, A, Gemperle Mannion, E, Parsons, H, Brown, J, Parsons, N, Fox, J, Kearney, R, Lawrence, T, Bush, H, McGowan, K, Khan, I, Mason, J, Hutchinson, C, Gates, S, Stallard, N, Underwood, M & Drew, S 2020, 'Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)', BMJ open, vol. 10, no. 5, e036829. https://doi.org/10.1136/bmjopen-2020-036829

APA

Metcalfe, A., Gemperle Mannion, E., Parsons, H., Brown, J., Parsons, N., Fox, J., Kearney, R., Lawrence, T., Bush, H., McGowan, K., Khan, I., Mason, J., Hutchinson, C., Gates, S., Stallard, N., Underwood, M., & Drew, S. (2020). Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS). BMJ open, 10(5), [e036829]. https://doi.org/10.1136/bmjopen-2020-036829

Vancouver

Author

Metcalfe, Andrew ; Gemperle Mannion, Elke ; Parsons, Helen ; Brown, Jaclyn ; Parsons, Nicholas ; Fox, Josephine ; Kearney, Rebecca ; Lawrence, Tom ; Bush, Howard ; McGowan, Kerri ; Khan, Iftekhar ; Mason, James ; Hutchinson, Charles ; Gates, Simon ; Stallard, Nigel ; Underwood, Martin ; Drew, Stephen. / Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons : a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS). In: BMJ open. 2020 ; Vol. 10, No. 5.

Bibtex

@article{88c717b4301e4d1f8d34d208e058b1e4,
title = "Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)",
abstract = "INTRODUCTION: Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.METHODS AND ANALYSIS: Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.ETHICS AND DISSEMINATION: NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.TRIAL REGISTRATION NUMBER: ISRCTN17825590.",
keywords = "adult orthopaedics, clinical trials, shoulder",
author = "Andrew Metcalfe and {Gemperle Mannion}, Elke and Helen Parsons and Jaclyn Brown and Nicholas Parsons and Josephine Fox and Rebecca Kearney and Tom Lawrence and Howard Bush and Kerri McGowan and Iftekhar Khan and James Mason and Charles Hutchinson and Simon Gates and Nigel Stallard and Martin Underwood and Stephen Drew",
note = "{\textcopyright} Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.",
year = "2020",
month = may,
day = "21",
doi = "10.1136/bmjopen-2020-036829",
language = "English",
volume = "10",
journal = "BMJ open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "5",

}

RIS

TY - JOUR

T1 - Protocol for a randomised controlled trial of Subacromial spacer for Tears Affecting Rotator cuff Tendons

T2 - a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS)

AU - Metcalfe, Andrew

AU - Gemperle Mannion, Elke

AU - Parsons, Helen

AU - Brown, Jaclyn

AU - Parsons, Nicholas

AU - Fox, Josephine

AU - Kearney, Rebecca

AU - Lawrence, Tom

AU - Bush, Howard

AU - McGowan, Kerri

AU - Khan, Iftekhar

AU - Mason, James

AU - Hutchinson, Charles

AU - Gates, Simon

AU - Stallard, Nigel

AU - Underwood, Martin

AU - Drew, Stephen

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

PY - 2020/5/21

Y1 - 2020/5/21

N2 - INTRODUCTION: Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.METHODS AND ANALYSIS: Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.ETHICS AND DISSEMINATION: NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.TRIAL REGISTRATION NUMBER: ISRCTN17825590.

AB - INTRODUCTION: Shoulder pain due to irreparable rotator cuff tears can cause substantial disability, but treatment options are limited. A balloon spacer is a relatively simple addition to a standard arthroscopic debridement procedure, but it is costly and there is no current randomised trial evidence to support its use. This trial will evaluate the clinical and cost-effectiveness of a subacromial balloon spacer for individuals undergoing arthroscopic debridement for irreparable rotator cuff tears.New surgical procedures can provide substantial benefit to patients. Good quality randomised controlled trials (RCTs) are needed, but trials in surgery are typically long and expensive, exposing patients to risk and the healthcare system to substantial costs. One way to improve the efficiency of trials is with an adaptive sample size. Such methods are well established in drug trials but have rarely, if ever, been used in surgical trials.METHODS AND ANALYSIS: Subacromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) is a participant and assessor blinded, adaptive, multicentre RCT comparing arthroscopic debridement with the InSpace balloon (Stryker, USA) to arthroscopic debridement alone for people with a symptomatic irreparable rotator cuff tear. It uses a group sequential adaptive design where interim analyses are performed using all of the 3, 6 and 12-month data that are available at each time point. A maximum of 221 participants will be randomised (1:1 ratio), this will provide 90% power (at the 5% level) for a 6 point difference in the primary outcome; the Oxford Shoulder Score at 12 months. A substudy will use deltoid-active MRI scans in 56 participants to assess the function of the balloon. Analysis will be on an intention-to-treat basis and reported according to principles established in the Consolidated Standards of Reporting Trials statement.ETHICS AND DISSEMINATION: NRES number 18/WM/0025. The results will be disseminated via peer-reviewed publications, presentations at conferences, lay summaries and social media.TRIAL REGISTRATION NUMBER: ISRCTN17825590.

KW - adult orthopaedics

KW - clinical trials

KW - shoulder

UR - http://www.scopus.com/inward/record.url?scp=85085263708&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2020-036829

DO - 10.1136/bmjopen-2020-036829

M3 - Article

C2 - 32444433

VL - 10

JO - BMJ open

JF - BMJ open

SN - 2044-6055

IS - 5

M1 - e036829

ER -