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.
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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.:
ClinicalTrials.gov processed this record on March 03, 2015
Fractured Humeral Head