RaCeR 2
Research type
Research Study
Full title
Clinical and cost-effectiveness of individualised (early) patient-directed rehabilitation versus standard rehabilitation after surgical repair of the rotator cuff of the shoulder: a multi-centre, randomised controlled trial with integrated Quintet Recruitment Intervention
IRAS ID
318438
Contact name
Rachelle Sherman
Contact email
Sponsor organisation
University Hospitals of Derby & Burton NHS Foundation Trust
ISRCTN Number
ISRCTN11499185
Duration of Study in the UK
3 years, 1 months, 31 days
Research summary
We are conducting a study focussing on the rehabilitation following surgery to repair the muscles and tendons of the shoulder (rotator cuff). We will recruit 638 patients across the country due to have arthroscopic rotator cuff surgery. Following surgery, they will be randomised to standard rehabilitation (4 weeks in a sling) or patient-directed rehabilitation (patients can choose to remove the sling when they feel able to). Patients will be followed up remotely via completion of questionnaires (choosing to complete these by post or online) at 12 weeks, 6 months and 12 months post randomisation. They will also document their sling use by completing a diary for 4 weeks following surgery. At 12 months, we will invite patients to attend for an ultrasound of their rotator cuff to assess for re-tear. The study also includes the "Quintet Recruitment Intervention" (QRI) which is a well-established study that is often embedded within large trials to monitor recruitment. This involves recording discussions about the study and offering advice and training to recruiters at site.
The study will be a host trial for a SWAT (Study Within a Trial) to explore participant characteristics and their choice of paper vs online questionnaire completion.REC name
London - Stanmore Research Ethics Committee
REC reference
23/LO/0195
Date of REC Opinion
13 Apr 2023
REC opinion
Further Information Favourable Opinion