A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

Terminated

• Conditions: Avascular Necrosis; Osteoarthritis; Humeral Fractures; Rheumatoid Arthritis

• Registration Number: NCT00698750
• Lead Sponsor: Biomet Orthopedics, LLC

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 will determine long-term clinical outcome while durability will be measured by the absence of revisions.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-13
• Study First Posted: 2008-06-17
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
X-rays	6 months, 1 year, 2 years, 3 years, 4 years, 5 years
ASES Assessment	6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Secondary Outcome Measures

Name	Time	Method
Incidence of revision or removals	Any time