Status:
ACTIVE_NOT_RECRUITING
Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Tampere University Hospital
Conditions:
Glenohumeral Osteoarthritis
Eligibility:
All Genders
55-85 years
Phase:
NA
Brief Summary
Anatomical total shoulder arthroplasty (TSA) is a well-established treatment for pronounced glenohumeral osteoarthritis. However, the effectiveness of TSA has not been compared to non-surgical treatme...
Detailed Description
Glenohumeral osteoarthritis causes pain, stiffness and weakness in the shoulder joint, and furthermore, it affects activities of daily living and quality of life. Anatomical total shoulder arthroplast...
Eligibility Criteria
Inclusion
- Patients ≥55-85 years
- Moderate-severe primary OA of the glenohumeral joint according to Samilson and Prieto, by measuring the lower osteophyte (32)
- Eligible for surgery with standard TSA
Exclusion
- Surgical need for bonegraft
- 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 :
June 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2035
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT04845074
Start Date
June 2 2021
End Date
November 1 2035
Last Update
April 15 2025
Active Locations (7)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200
2
Esbjerg Hospital
Esbjerg, Denmark, 6700
3
Aalborg University Hospital
Farsø, Denmark, 9640
4
Silkeborg Regional Hospital
Silkeborg, Denmark, 8600