- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00698750
A Clinical Investigation of the Copeland™ Humeral Resurfacing Head
June 19, 2017 updated by: Biomet Orthopedics, LLC
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 Overview
Status
Terminated
Study Type
Observational
Enrollment (Actual)
34
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients requiring humeral resurfacing.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Copeland™ Humeral Resurfacing Head
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ASES Assessment
Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
X-rays
Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of revision or removals
Time Frame: Any time
|
Any time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kenneth J Beres, MD, Director, Clinical Research, Biomet Orthopedics, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
November 1, 2009
Study Registration Dates
First Submitted
June 13, 2008
First Submitted That Met QC Criteria
June 13, 2008
First Posted (Estimate)
June 17, 2008
Study Record Updates
Last Update Posted (Actual)
June 21, 2017
Last Update Submitted That Met QC Criteria
June 19, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Biomet 12381-30
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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