A Clinical Investigation of the Copeland™ Humeral Resurfacing Head - Full Text View

Sponsor:	Biomet Orthopedics, LLC
Information provided by:	Biomet, Inc.
ClinicalTrials.gov Identifier:	NCT00698750

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:

MedlinePlus related topics: Fractures Osteoarthritis Rheumatoid Arthritis

U.S. FDA Resources

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 ]

Estimated Enrollment:	160
Study Start Date:	April 2004
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2015 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00698750

Sponsors and Collaborators

Biomet Orthopedics, LLC

Investigators

Study Director:

Kenneth J Beres, MD

Director, Clinical Research, Biomet Orthopedics, LLC

More Information

No publications provided

Responsible Party:	Kenneth Beres, MD Director Clinical Research, 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:	November 9, 2009
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 23, 2012