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Sponsored by: |
University of Aarhus |
Information provided by: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT00408096 |
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.
Condition | Intervention |
Osteoarthritis |
Procedure: Copeland or Global CAP resurfacing prosthesis |
MedlinePlus related topics: | Osteoarthritis |
Drug Information available for: | Durapatite |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study |
Estimated Enrollment: | 60 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area.
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Procedure: Copeland or Global CAP resurfacing prosthesis
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
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2: Active Comparator
The Global Cap uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area.
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Procedure: Copeland or Global CAP resurfacing prosthesis
Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.
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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):
Radiologic parameters:
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Maiken Stilling, MD | +45 89 49 74 66 | MAIKEN.STILLING@KI.AU.DK |
Contact: Inger B Mechlenburg, MSc | +45 65371093 | INGER.MECHLENBURG@KI.AU.DK |
Denmark | |||||
Orthopaedic Department K, Silkeborg Hospital | Recruiting | ||||
Silkeborg, Denmark, 8600 | |||||
Contact: Thomas Klebe, MD +45 87 22 27 66 kotmk@sc.aaa.dk | |||||
Principal Investigator: Maiken Stilling, MD |
University of Aarhus |
Study Director: | Kjeld Soballe, Professor | Orthopaedic Department, Aarhus University Hospital |
Responsible Party: | Aarhus University Hospital ( Maiken Stilling, MD ) |
Study ID Numbers: | 20060165 |
First Received: | December 5, 2006 |
Last Updated: | July 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00408096 |
Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
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