Status:
TERMINATED
A Clinical Investigation of the Copeland™ Humeral Resurfacing Head
Lead Sponsor:
Biomet Orthopedics, LLC
Conditions:
Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00698750
Start Date
April 1 2004
End Date
November 1 2009
Last Update
June 21 2017
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