Comparing shoulder surgery to exercise for rotator cuff problems
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy Eligible For Reverse Shoulder Arthroplasty: the ReAct Multicenter, Randomized Controlled Trial
This study tests whether shoulder surgery or a 12-week exercise program works better for people with rotator cuff problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 102 (estimated) |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 8 sites (Aarhus N and 7 other locations) |
| Trial ID | NCT04864158 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of reverse shoulder arthroplasty (RSA) compared to a 12-week physiotherapist-supervised exercise program in patients with rotator cuff arthropathy. Participants eligible for RSA will be randomly assigned to either receive the surgical intervention followed by standard rehabilitation or to engage solely in the exercise program. The primary outcome will be assessed using the Western Ontario Osteoarthritis of the Shoulder index score at 12 months, with follow-ups at various intervals. The study aims to determine if surgical treatment leads to significantly better outcomes than non-surgical exercise therapy.
Who should consider this trial
Good fit: Ideal candidates are patients aged 60-85 years with rotator cuff arthropathy eligible for reverse shoulder arthroplasty.
Not a fit: Patients with previous shoulder fractures, other types of arthritis, or neurological diseases affecting shoulder mobility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for the most effective treatment approach for patients with rotator cuff arthropathy, potentially improving pain management and functional outcomes.
How similar studies have performed: Previous studies have suggested the need for trials comparing surgical and non-surgical treatments for shoulder conditions, indicating that this approach is novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients 60-85 years * Eligible for RSA * Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33) Exclusion Criteria: * Previous shoulder fracture (fracture of the proximal humerus or glenoid fracture) * Planned other upper extremity surgery within six months * Rheumatoid arthritis or other types of arthritis not diagnosed as primary glenohumeral OA * Cancer diagnosis and receiving chemo-, immuno- or radiotherapy * Neurological diseases affecting shoulder mobility (e.g. disability after previous stroke, multiple sclerosis, Parkinson's, Alzheimer's disease) * Other reasons for exclusion (i.e. mentally unable to participate) or planned absence for more than 14 days in the first 3 months after baseline test. * Unable to communicate in the participating countries respective languages
Where this trial is running
Aarhus N and 7 other locations
- Aarhus University Hospital — Aarhus N, Denmark (Recruiting)
- Esbjerg Hospital — Esbjerg, Denmark (Recruiting)
- Aalborg University Hospital — Farsø, Denmark (Recruiting)
- Silkeborg Regional Hospital — Silkeborg, Denmark (Recruiting)
- Viborg Regional Hospital — Viborg, Denmark (Recruiting)
- Tartu University Hospital — Tartu, Estonia (Recruiting)
- Tampere University Hospital — Tampere, Finland (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Josefine B. Larsen, MSc — Aarhus University Hospital and Aarhus University
- Study coordinator: Josefine B. Larsen, MSc
- Email: josefinebl@clin.au.dk
- Phone: 4526237771
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.