SSORT UK Research Study
SHOULDER SURGERY OR REHABILITATION TRIAL (UK)
Registered with National Institutes of Health Clinical Trials Protocol Registration System in December 2012. ClinicalTrials.gov Identifier: NCT01751490
- Royal National Orthopaedic Hospital NHS Trust, Stanmore, UK
- Neuroscience Research Australia, Randwick, Australia
- Wrightington, Wigan & Leigh NHS Foundation Trust, Wrightington Hospital, UK
- Sydney Medical School, The University of Sydney, Australia
Shoulder instability is a common problem affecting young adults. Stabilization surgery followed by physiotherapy rehabilitation has been shown to reduce further episodes of shoulder dislocation following traumatic shoulder dislocations, but it is unclear if surgical intervention is beneficial for patients with atraumatic shoulder instability.
The aim of this randomized controlled clinical trial is to determine if the addition of surgical intervention to physiotherapy rehabilitation improves outcomes for patients with atraumatic shoulder instability who have sustained soft tissue damage at their joint.
This trial will have a direct and immediate impact on clinical decision making by establishing if patients presenting with atraumatic shoulder instability should be referred for stabilization surgery before commencing physiotherapy rehabilitation in order to ensure optimal outcome.
The study started in 2013 and the plan is to recruit 140 participants. Patients with feelings of insecurity (apprehension) at their shoulder joint, which is not the result of a collision injury, with physical signs of shoulder joint instability will be invited to participate. Consenting participants will undergo arthroscopic investigation of the shoulder joint. Patients with capsulolabral damage will be randomly allocated using a concealed allocation procedure either to stabilization surgery immediately following the arthroscopic examination or no additional surgical procedure. All participants will then receive the same postoperative physiotherapy protocol for up to 6 months. Outcomes (pain, functional impairment and number of shoulder dislocations sustained) will be evaluated prior to surgery and, together with participant-reported improvement, again at 6, 12 and 24 months after randomization. Participants, clinical staff (but not surgeons) and assessors will be blind to whether stabilization surgery was performed. Data analysis will be conducted on an intention-to-treat basis with the focus on estimation of the effect.
How can you help?
Clinicians - we are trying to recruit as many patients as possible. If you feel you have a suitable patient and are based in the UK, please refer the patient to Stanmore Hospital in the South or Wrightington Hospital in the North.
Patients - If you feel you would like to participate in the study, please discuss with your doctor or contact us.
Reference: Jaggi A, Alexander S, Herbert, R, Funk L, Ginn, K. Does surgery followed by physiotherapy improve short and long term outcome for patients with atraumatic shoulder instability compared with physiotherapy alone? - protocol for a randomized controlled clinical trial. BMC Musculoskeletal Disorders 2014, 15:439. doi:10.1186/1471-2474-15-439. http://www.biomedcentral.com/1471-2474/15/439