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.)
Sponsor:
Biomet Orthopedics, LLC
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00698750
First received: June 13, 2008
Last updated: August 14, 2012
Last verified: August 2012
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Purpose
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.
| Condition |
|---|
|
Osteoarthritis Rheumatoid Arthritis Avascular Necrosis Humeral Fractures |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Prospective, Non-controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head |
Resource links provided by NLM:
Further study details as provided by Biomet, Inc.:
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 ]
| Enrollment: | 34 |
| Study Start Date: | April 2004 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Copeland™ Humeral Resurfacing Head
Copeland™ Humeral Resurfacing Head
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients requiring humeral resurfacing.
Criteria
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Biomet, Inc. ( Biomet Orthopedics, LLC ) |
| ClinicalTrials.gov Identifier: | NCT00698750 History of Changes |
| Other Study ID Numbers: | Biomet 12381-30 |
| Study First Received: | June 13, 2008 |
| Last Updated: | August 14, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biomet, Inc.:
|
Fractured Humeral Head Traumatic Arthritis Resurfacing Shoulder Shoulder Replacement Shoulder Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Humeral Fractures Necrosis Osteonecrosis Osteoarthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Arm Injuries Wounds and Injuries Fractures, Bone Pathologic Processes Bone Diseases |
ClinicalTrials.gov processed this record on May 22, 2013