SORTED – a randomised controlled superiority trial comparing the clinical and cost-effectiveness of the addition of surgery to a patient’s treatment pathway versus non-operative rehabilitation alone for young adult patients with a first-time shoulder dislocation
Shoulder dislocation
The trial is a multi-centre, 2-arm, parallel design, superiority randomised controlled trial with an embedded internal pilot (first six months of recruitment). The trial (including the internal pilot) will recruit 276 patients (138 in each of two groups) with a first-time shoulder dislocation from a minimum of 20 sites in the UK. Participants will be individually randomised (1:1) to receive either arthroscopic shoulder stabilisation + shoulder stability rehabilitation or shoulder stability rehabilitation alone. Participants will be followed up for 15 months post-randomisation. Patients considered potentially eligible will be approached by their usual care team on behalf of the research team or if their usual care team is also part of the site research team, they may discuss the trial directly with the patient. They will be provided with a Participant Information Sheet (PIS) and a link to the trial website/trial explainer animation. For those patients that are potentially interested in learning more, they will be directed to contact the local site research team to discuss further. If they wish to proceed with participation they will provide informed consent. Participants will then complete baseline questionnaires based on how they were feeling before their injury (answered retrospectively) and how they are feeling today. Participants will then be randomised to either treatment group and followed up at 3, 6, 9, 12 and 15 months post-randomisation. Data will be collected via the clinical trial IT system REDCap, hosted by the University of Oxford, UK. Baseline demographic data will be entered directly by the site staff during the initial visit, and all baseline questionnaire data will be entered directly by the participant. Participants will then be contacted for follow-up to complete questionnaires through an online link. Telephone and postal follow-up will be conducted for those who require it. Follow-up will be conducted centrally by the trial team.
1. Aged between 16 and 30 years old 2. Medical imaging confirms dislocation of the shoulder
1. Injury is more than 28 days old 2. The dislocation is recurrent 3. The dislocation is atraumatic 4. Patient has bilateral shoulder dislocations 5. Patient is unable to adhere to trial interventions or follow-up If further imagining is done for clinical reasons, additional exclusion criteria will apply: 6. Medical imaging suggests bone loss off the glenoid > 20% its diameter. 7. The shoulder dislocation is associated with a fracture of the humeral head (other than a “Hill-Sachs” fracture) 8. Evidence of full thickness rotator cuff tear, Humeral avulsion of the glenohumeral ligament, lesion or a labral tear that extends all the way around the glenoid (pan-labral tear)