Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00408096
• Date of registration: 05/12/2006
• Prospective Registration: No
• Primary sponsor: University of Aarhus
• Public title: Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder
• Scientific title: Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study
• Date of first enrolment: December 2006
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00408096
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Denmark

Contacts

• Name: Kjeld Soballe, Professor
• Affiliation: Orthopaedic Department, Aarhus University Hospital

Key inclusion & exclusion criteria

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) -



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis

Intervention(s)

Procedure: Copeland or Global CAP resurfacing prosthesis

Primary Outcome(s)

Activities of Daily Living (ADL) [Time Frame: five years]

Migration of resurfacing prostheses [Time Frame: five years]

Pain [Time Frame: five years]

Bone density around the prosthesis [Time Frame: five years]

Secondary Outcome(s)

Correlation between bone density and prosthesis migration [Time Frame: five years]

Muscle strength [Time Frame: five years]

Range of Motion (ROM) [Time Frame: five years]

Secondary ID(s)

20060165

Source(s) of Monetary Support

Please refer to primary and secondary sponsors