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Sub-acromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) : statistical analysis plan
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Parsons, Helen and Haque, Aminul (2021) Sub-acromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) : statistical analysis plan. University of Warwick, Warwick Medical School, Warwick Clinical Trials Unit.
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Abstract
Statistical Analysis Plan (SAP) for the Sub-acromial spacer for Tears Affecting Rotator cuff Tendons: a Randomised, Efficient, Adaptive Clinical Trial in Surgery (START:REACTS) Trial.
This SAP describes the detailed statistical analysis plan for the START:REACTS study as agreed by the DMC and approved by the Chief Investigator prior to analyses taking place.
START:REACTS is a multi-centre randomised controlled trial to assess the difference in clinical and cost effectiveness between arthroscopic debridement of the subacromial space and arthroscopic debridement with insertion of an InSpace balloon (Stryker, USA). More details can be found on the study website https://warwick.ac.uk/fac/sci/med/research/ctu/trials/startreacts
START:REACTS is a ISRCTN registered clinical trial ISRCTN17825590 (https://www.isrctn.com/ISRCTN17825590) and was funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership.
Item Type: | Report | ||||||
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Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Publisher: | University of Warwick, Warwick Medical School, Warwick Clinical Trials Unit | ||||||
Official Date: | 2021 | ||||||
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Institution: | University of Warwick | ||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||
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