A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00698750
• Other study ID #: Biomet 12381-30
• Status: Terminated
• Phase: N/A
• First received: June 13, 2008
• Last updated: June 19, 2017
• Start date: April 2004
• Est. completion date: November 2009

Study information

• Verified date: June 2017
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Avascular Necrosis
• Humeral Fractures
• Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biomet Orthopedics, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASES Assessment		6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Primary	X-rays		6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Incidence of revision or removals		Any time