Overview

This trial is active, not recruiting.

Condition osteoarthritis
Treatment copeland or global cap resurfacing prosthesis
Sponsor University of Aarhus
Start date December 2006
End date January 2017
Trial size 60 participants
Trial identifier NCT00408096, 20060165

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis
copeland or global cap resurfacing prosthesis
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
(Active Comparator)
The Global Cap uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis
copeland or global cap resurfacing prosthesis
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.

Primary Outcomes

Measure
Migration of resurfacing prostheses
time frame: five years
Bone density around the prosthesis
time frame: five years
Pain
time frame: five years
Activities of Daily Living (ADL)
time frame: five years

Secondary Outcomes

Measure
Range of Motion (ROM)
time frame: five years
Muscle strength
time frame: five years
Correlation between bone density and prosthesis migration
time frame: five years

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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) -

Additional Information

Official title Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study
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
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by University of Aarhus.