A Clinical Investigation of the Copeland™ Humeral Resurfacing Head
This study has been terminated.
(Sponsor terminated study early due to limited enrollment and follow-up.)
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
First received: June 13, 2008
Last updated: August 14, 2012
Last verified: August 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||A Prospective, Non-controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head
Primary Outcome Measures:
- ASES Assessment [ Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ] [ Designated as safety issue: No ]
- X-rays [ Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of revision or removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2009 (Final data collection date for primary outcome measure)
Copeland™ Humeral Resurfacing Head
Copeland™ Humeral Resurfacing Head
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients requiring humeral resurfacing.
- 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
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00698750
Biomet Orthopedics, LLC
||Kenneth J Beres, MD
||Director, Clinical Research, Biomet Orthopedics, LLC
No publications provided
||Biomet, Inc. ( Biomet Orthopedics, LLC )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 13, 2008
||August 14, 2012
||United States: Institutional Review Board
Keywords provided by Biomet, Inc.:
Fractured Humeral Head
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 21, 2014
Connective Tissue Diseases
Immune System Diseases
Wounds and Injuries