A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

This study has been terminated.
(Sponsor terminated study early due to limited enrollment and follow-up.)
Sponsor:
Information provided by (Responsible Party):
Biomet, Inc. ( Biomet Orthopedics, LLC )
ClinicalTrials.gov Identifier:
NCT00698750
First received: June 13, 2008
Last updated: August 14, 2012
Last verified: August 2012
  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:


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 ]

Enrollment: 34
Study Start Date: April 2004
Study Completion Date: November 2009
Primary Completion Date: November 2009 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Biomet, Inc. ( 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: August 14, 2012
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
Osteoarthritis
Arm Injuries
Autoimmune Diseases
Connective Tissue Diseases
Fractures, Bone
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Wounds and Injuries

ClinicalTrials.gov processed this record on October 21, 2014