A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

Study Overview
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Brief Summary
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The purpose of this study is to perform a five-year, prospective evaluation of the Copeland™ Humeral Resurfacing Head Prosthesis for outcome and durability. Relief of pain and restoration of function will determine long-term clinical outcome while durability will be measured by the absence of revisions.

Official Title
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A Prospective, Non-controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head

Conditions
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Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis, Humeral Fractures

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. Rheumatoid arthritis Correction of functional deformity Reconstructable Rotator Cuff Treatment of acute fracture of the humeral head Traumatic arthritis Exclusion Criteria: Patients less than 18 years. Patients with rapid joint destruction, osteomalacia, osteoporosis, or marked bone loss, which would preclude proper fixation of the prosthesis. Patients with marked bone loss apparent on roentgenogram. Metabolic disorders, which may impair bone formation. Patients who are pregnant. Patients with an active or suspected infection in or around the shoulder or distant foci of infections, which may spread to the implant site. Patients with severe instability or deformity of the ligaments and/or surrounding soft tissue, which would prelude stability of the prosthesis. Patients who have had revision procedures where other devices or treatments have failed. Patients with a highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, neoplastic disease, etc). Patients unwilling or unable to comply with a rehabilitation program for a cemented or cementless partial or total shoulder replacement or who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol. Patients with previous shoulder surgery or conditions that may interfere with the partial or total shoulder replacement's survival or outcome. Patients who qualify for inclusion in the study, but refuse consent to participate in the study. Patients who have had a partial or total shoulder arthroplasty on the contralateral shoulder within the last year.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Copeland™ Humeral Resurfacing Head<br>Copeland™ Humeral Resurfacing Head | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASES Assessment |  | 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | 
| X-rays |  | 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of revision or removals |  | Any time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fractured Humeral Head, Traumatic Arthritis, Resurfacing Shoulder, Shoulder Replacement, Shoulder Arthritis