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NCT04864158
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
Conditions: Rotator Cuff Arthropathy
Sex: All
Ages: 60 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 102
Sponsor: University of Aarhus
Location: Aarhus University Hospital Aarhus N
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT04864158). StuddyBuddy aggregates publicly available trial information.