Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. However, the effectiveness of RSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral
| Condition(s) | Rotator Cuff Arthropathy |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Reverse shoulder arthroplasty (RSA) is a well-established treatment for rotator cuff arthropathy. However, the effectiveness of RSA has not been compared to non-surgical treatment in a randomised controlled trial. Shoulder exercises may be an effective treatment for reducing pain and improving function in glenohumeral osteoarthritis. The primary aim of this trial is to examine if RSA followed by standard postsurgical rehabilitation is superior to a 12-week exercise programme in patients with rotator cuff arthropathy eligible for unilateral RSA. The investigators hypothesise that surgical intervention followed by standard rehabilitation, results in clinically relevant (14-point, on a scale from 0-100) improvement compared to the exercise intervention. |
| Who can participate | 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 countri |
| Ages | 60 Years to 85 Years |
| Sex | All |
| Lead sponsor | University of Aarhus |
| Locations | Aarhus N, Denmark; Esbjerg, Denmark; Farsø, Denmark; Silkeborg, Denmark; Viborg, Denmark; Tartu, Estonia (+2 more sites) |
| Start date | 2021-05-28 |
| NCT ID | NCT04864158 |
| Official listing | https://clinicaltrials.gov/study/NCT04864158 |