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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 13, 2008

Last Updated Date

February 25, 2009

Start Date ^†

April 2004

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00698750 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Incidence of revision or removals [ Time Frame: Any time ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

Official Title ^†

A Prospective, Non-Controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Cohort, Prospective

Condition ^†

Osteoarthritis
Rheumatoid Arthritis
Avascular Necrosis
Humeral Fractures

Intervention ^†

Study Arms / Comparison Groups

Copeland™ Humeral Resurfacing Head

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Estimated Enrollment ^†

160

Estimated Completion Date

April 2015

Estimated Primary Completion Date

April 2015 (final data collection date for primary outcome measure)

Eligibility 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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00698750

Responsible Party

Kenneth Beres, MD Director Clinical Research, Biomet Orthopedics, LLC

Secondary IDs ^††

Study Sponsor ^†

Biomet Orthopedics, LLC

Collaborators ^††

Investigators ^†

Study Director:

Kenneth J Beres, MD

Director, Clinical Research, Biomet Orthopedics, LLC

Information Provided By

Biomet, Inc.

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.