A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

Condition(s) targeted: Osteoarthritis; Rheumatoid Arthritis; Avascular Necrosis; Humeral Fractures

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Biomet Orthopedics, Inc.

Official(s) and/or principal investigator(s):
Kenneth J Beres, MD, Study Director, Affiliation: Director, Clinical Research, Biomet Orthopedics, Inc

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.

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

Study design: Cohort, Prospective

Primary outcome:

ASES Assessment

X-rays

Secondary outcome: Incidence of revision or removals

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: April 2004
Ending date: April 2015
Last updated: June 13, 2008