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

Study Overview
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Brief Summary
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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
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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): Pain Activities of Daily Living (ADL) Range of Motion (ROM) Muscle strength Radiologic parameters: Migration of resurfacing prostheses with use of MB-RSA Bone density around the prosthesis measured with Dual Energy X-ray Absorptiometry (DEXA) Correlation between bone density and prosthesis migration

Official Title
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Comparison of Two Resurfacing Prostheses in the Treatment of Osteoarthritis of the Shoulder A Prospective, Randomized Migration and Bone Density Study

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Copeland or Global CAP resurfacing prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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) -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>The Copeland uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis | Procedure: Copeland or Global CAP resurfacing prosthesis<br>* Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.<br>|
| Active Comparator: 2<br>The Global Cap uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact area used as a treatment for shoulder osteoarthritis | Procedure: Copeland or Global CAP resurfacing prosthesis<br>* Both Copeland and Global Cap are uncemented prostheses with titanium-sprayed, hydroxyapatite (HA)-coated bone-contact surfaces.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion (ROM) |  | five years | 
| Muscle strength |  | five years | 
| Correlation between bone density and prosthesis migration |  | five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, shoulder, resurfacing, prosthesis