Osteoarthritis
Conditions
Keywords
osteoarthritis, shoulder, resurfacing, prosthesis
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 Copeland resurfacing prosthesis and the Global CAP resurfacing prosthesis. Clinical parameters with the help of the Constant Shoulder Score (CSS) and Western Ontario Osteoarthritis of the Shoulder Index (WOOS): 1. Pain 2. Activities of Daily Living (ADL) 3. Range of Motion (ROM) 4. Muscle strength Radiologic parameters: 1. Migration of resurfacing prostheses with use of MB-RSA 2. Bone density around the prosthesis measured with Dual Energy X-ray Absorptiometry (DEXA) 3. Correlation between bone density and prosthesis migration
Interventions
PROCEDURECopeland or Global CAP resurfacing prosthesis
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with shoulder osteoarthritis with cartilage defect of the caput humeri and not the glenoid cavity 2. Aged 18 years or older and fit 3. Informed, written consent -
Exclusion criteria
1. Patients found unsuitable preoperatively for a resurfacing prosthesis 2. Patients aged 85 or older 3. Patients with rheumatoid arthritis 4. Patients who previously had undergone shoulder alloplasty or other major shoulder surgery (more than just diagnostic arthroscopy) 5. Patients unable to avoid NSAID after surgery 6. Patients requiring regular systemic steroid treatment 7. Female patients taking hormone substitution 8. Patients with metabolic bone disease 9. Severe shoulder instability with large rotator cuff defect ( will often necessitate special prosthesis components or even major soft-tissue surgery) 10. Female patients in the fertile age range who do not use safe anti-conception (oral contraception, intrauterine devices, depot gestagens, vaginal hormone rings) -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Migration of resurfacing prostheses | five years |
| Bone density around the prosthesis | five years |
| Pain | five years |
| Activities of Daily Living (ADL) | five years |
Secondary
| Measure | Time frame |
|---|---|
| Muscle strength | five years |
| Correlation between bone density and prosthesis migration | five years |
| Range of Motion (ROM) | five years |
Countries
Denmark
Outcome results
None listed