A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

June 19, 2017 updated by: Biomet Orthopedics, LLC

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring humeral resurfacing.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Copeland™ Humeral Resurfacing Head

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ASES Assessment Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	6 months, 1 year, 2 years, 3 years, 4 years, 5 years
X-rays Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of revision or removals Time Frame: Any time	Any time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biomet Orthopedics, LLC

Investigators

Study Director: Kenneth J Beres, MD, Director, Clinical Research, Biomet Orthopedics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

June 13, 2008

First Submitted That Met QC Criteria