Status:
RECRUITING
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Tampere University Hospital
Conditions:
Rotator Cuff Arthropathy
Eligibility:
All Genders
60-85 years
Phase:
NA
Brief 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 cont...
Detailed Description
Rotator cuff arthropathy describes the clinical scenario of massive rotator cuff ruptures associated with glenohumeral joint degeneration and superior migration of the humeral head. Clinical presentat...
Eligibility Criteria
Inclusion
- Patients 60-85 years
- Eligible for RSA
- Rotator cuff arthropathy according to Hamada grade 3, 4 and 5 (33)
Exclusion
- 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
Key Trial Info
Start Date :
May 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2038
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04864158
Start Date
May 28 2021
End Date
November 1 2038
Last Update
April 17 2025
Active Locations (8)
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1
Aarhus University Hospital
Aarhus N, Denmark
2
Esbjerg Hospital
Esbjerg, Denmark, 6700
3
Aalborg University Hospital
Farsø, Denmark, 9640
4
Silkeborg Regional Hospital
Silkeborg, Denmark, 8600