Status:
COMPLETED
Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder
Lead Sponsor:
University of Aarhus
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to determine whether there is a difference between the result of treatment of shoulder osteoarthritis with two different shoulder prostheses.
Detailed Description
In this randomized study, we wish to investigate with the use of clinical and radiological parameters whether there is a difference between the result of treatment of shoulder osteoarthritis with the ...
Eligibility Criteria
Inclusion
- Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity
- Aged 18 years or older and fit
- Informed, written consent -
Exclusion
- Patients found unsuitable preoperatively for a resurfacing prosthesis
- Patients aged 85 or older
- Patients with rheumatoid arthritis
- Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy)
- Patients unable to avoid NSAID after surgery
- Patients requiring regular systemic steroid treatment
- Female patients taking hormone substitution
- Patients with metabolic bone disease
- Severe shoulder instability with large rotator cuff defect ( will often necessitate special prosthesis components or even major soft-tissue surgery)
- Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings) -
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00408096
Start Date
December 1 2006
End Date
January 1 2018
Last Update
August 16 2018
Active Locations (2)
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1
Orthopaedic Department K, Silkeborg Hospital
Silkeborg, Denmark, 8600
2
Regionshospitalet Viborg
Viborg, Denmark, 8800