Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Investigation of the Copeland™ Humeral Resurfacing Head

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00698750
Recruitment Status : Terminated (Sponsor terminated study early due to limited enrollment and follow-up.)
First Posted : June 17, 2008
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet ( Biomet Orthopedics, LLC )

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.

Condition or disease
Osteoarthritis Rheumatoid Arthritis Avascular Necrosis Humeral Fractures

Layout table for study information
Study Type : Observational
Actual Enrollment : 34 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-controlled, Clinical Investigation of the Copeland™ Humeral Resurfacing Head
Study Start Date : April 2004
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine


Group/Cohort
Copeland™ Humeral Resurfacing Head
Copeland™ Humeral Resurfacing Head



Primary Outcome Measures :
  1. ASES Assessment [ Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
  2. X-rays [ Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]

Secondary Outcome Measures :
  1. Incidence of revision or removals [ Time Frame: Any time ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698750


Sponsors and Collaborators
Biomet Orthopedics, LLC
Investigators
Layout table for investigator information
Study Director: Kenneth J Beres, MD Director, Clinical Research, Biomet Orthopedics, LLC
Layout table for additonal information
Responsible Party: Biomet Orthopedics, LLC
ClinicalTrials.gov Identifier: NCT00698750    
Other Study ID Numbers: Biomet 12381-30
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Keywords provided by Zimmer Biomet ( Biomet Orthopedics, LLC ):
Fractured Humeral Head
Traumatic Arthritis
Resurfacing Shoulder
Shoulder Replacement
Shoulder Arthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Necrosis
Humeral Fractures
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Arm Injuries
Wounds and Injuries
Fractures, Bone