Official Title: “A Prospective, Non-Controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head”

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.

Study Type: Observational

Study Design: Cohort, Prospective

Study Primary Completion Date: April 2015

Arms, Groups and Cohorts in this Clinical Trial

• : Copeland™ Humeral Resurfacing Head
  • Copeland™ Humeral Resurfacing Head

Primary Measures

• ASES Assessment
  • Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
    Safety Issue?: No
• X-rays
  • Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
    Safety Issue?: No

Secondary Measures

• Incidence of revision or removals
  • Time Frame: Any time
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Biomet Orthopedics, LLC

Overall Clinical Trial Officials and Contacts

Kenneth J Beres, MD Study Director Director, Clinical Research, Biomet Orthopedics, LLC  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00698750

Study ID Number: Biomet 12381-30

ClinicalTrials.gov Identifier: NCT00698750

Health Authority: United States: Institutional Review Board