Surgery or rehabilitation for traumatic shoulder dislocations
| ISRCTN | ISRCTN17897617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17897617 |
| Integrated Research Application System (IRAS) | 348387 |
| Central Portfolio Management System (CPMS) | 64362 |
| National Institute for Health and Care Research (NIHR) | 167370 |
| Sponsor | University of Oxford |
| Funder | National Institute for Health and Care Research |
- Submission date
- 06/05/2026
- Registration date
- 07/05/2026
- Last edited
- 07/05/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
The SORTED trial aims to establish the best way to treat young adults who dislocate their shoulders for the first time. This is a common injury, that usually results from an accident whilst playing sport. Currently, there are two main treatments used to minimise the risk of patients dislocating the shoulder again in the future: immediate keyhole surgery, followed by physiotherapy or physiotherapy alone. If a patient’s shoulder does not stabilise after an initial dislocation it can lead to ongoing pain, reduced quality of life, and there could be complications like nerve injuries. This trial is crucial in determining the most effective and cost-efficient initial treatment to prevent recurrent instability and its negative consequences.
Who can participate?
Younger people are much more likely to dislocate their shoulders than others, and this trial will focus on people aged 16 to 30 years.
What does the study involve?
Participants will receive either keyhole shoulder surgery followed by rehabilitation, or rehabilitation alone. They will be involved in the study for 15 months and asked to complete questionnaires about their treatment and shoulder recovery at regular intervals.
What are the possible benefits and risks of participating?
Both treatments are standard NHS care and taking part in the study does not add extra risk. Surgery carries known risks such as infection and anaesthetic complications but may reduce the chance of future shoulder dislocations. Non-surgical treatment avoids surgery risks but may increase the chance of the shoulder dislocating again. Rehabilitation exercises may cause temporary discomfort or stiffness.
Where is the study run from?
The University of Oxford (UK)
When is the study starting and how long is it expected to run for?
May 2026 to April 2033
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK).
Who is the main contact?
Trial Manager - Miss Hannah Crook
Chief Investigator - Associate Professor Steve Gwilym
sorted@ndorms.ox.ac.uk
Contact information
Public, Scientific, Principal investigator
Kadoorie Centre, Level 3, John Radcliffe Hospital, Headley Way, Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 1865 227912 |
|---|---|
| sorted@ndorms.ox.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study acronym | SORTED |
| Study objectives | Primary Objective - Shoulder function as reported by the participant at 15 months post-randomisation using the Oxford Shoulder Instability Score (OSIS) Secondary Objectives: 1. Shoulder function (OSIS) at Baseline (pre-injury), 3, 6, 9 and 12 months post-randomisation 2. Health related quality of life (EQ-5D-5L) at Baseline (pre and post injury), 3, 6, 9, 12 and 15 months post randomisation 3. Cost and comparative cost-effectiveness (bespoke participant resource use questionnaire) at 3, 6, 9, 12 and 15 months post-randomisation 4. Complications, including re-dislocation, reported by participants at 3, 6, 9, 12 and 15 months post-randomisation and sites at 6 and 15 months post-randomisation 5. Fear of movement and return to sport (SIRSI) at 3, 6, 9, 12 and 15 months post-randomisation 6. Shoulder function satisfaction (bespoke participant questionnaire) at Baseline (pre-injury), 3, 6, 9, 12 and 15 months post-randomisation 7. Long-term rate of re-dislocation and further surgery up to 5 years post-randomisation via linkage to NHS digital (or equivalent) |
| Ethics approval(s) |
Approved 23/04/2026, London - Camden & Kings Cross Research Ethics Committee (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8086; CamdenandKingsCross.REC@hra.nhs.uk), ref: 26/LO/0248 |
| Health condition(s) or problem(s) studied | Shoulder dislocation |
| Intervention | 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. |
| Intervention type | Mixed |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 30/04/2033 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 30 Years |
| Sex | All |
| Target sample size at registration | 276 |
| Key inclusion criteria | 1. Aged between 16 and 30 years old 2. Medical imaging confirms dislocation of the shoulder |
| Key exclusion criteria | 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) |
| Date of first enrolment | 11/05/2026 |
| Date of final enrolment | 31/01/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Hills Road
Cambridge
CB2 0QQ
England
Skipton Road
Steeton
Keighley
BD20 6TD
England
Dalmellington Road
Ayr
KA6 6AB
Scotland
80 Newark Street
London
E1 2ES
England
Hollyhurst Road
Darlington
DL3 6HX
England
Uttoxeter Road
Derby
DE22 3NE
England
Aldermaston Road
Basingstoke
RG24 9NA
England
Eaglestone
Milton Keynes
MK6 5LD
England
Bretton Gate
Bretton
Peterborough
PE3 9GZ
England
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
England
Treliske
Truro
TR1 3LJ
England
East Surrey Hospital
Canada Avenue
Redhill
RH1 5RH
England
Headley Way
Headington
Oxford
OX3 9DU
England
London
SE5 9RS
England
Infirmary Square
Leicester
LE1 5WW
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
06/05/2026: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
