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CoMplete™ Acetabular Hip System

This study has been terminated.
(Sponsor withdrew PMA)
Sponsor:
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01543230
First received: February 27, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

The primary objective of this investigation is to evaluate survivorship at ten years. For this post approval study (PAS), a maximum acceptable hazard of revision is assumed to be a constant 1% per year.


Condition Intervention
Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Post-traumatic Arthritis
Device: Total hip replacement

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System

Resource links provided by NLM:


Further study details as provided by DePuy Orthopaedics:

Primary Outcome Measures:
  • Survivorship [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
    Subjects will be seen each year through year 5 postoperatively for radiographic and clinical follow-up, and then at 8 and 10 years postoperatively for radiographic and clinical follow-up. Survivorship means the removal of either or both of the components (ceramic head or metal liner).


Secondary Outcome Measures:
  • Metal Ion Levels [ Time Frame: 5 years, 8 years, and 10 years postoperatively ] [ Designated as safety issue: Yes ]
    A subset of subjects will be measured for serum cobalt, serum chromium, erythrocytes cobalt, erythrocytes chromium, whole blood cobalt, and whole blood chromium levels. These subjects will also be measured for BUN and creatine levels.


Enrollment: 58
Study Start Date: February 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoMplete™ Acetabular Hip System (CoM)
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Device: Total hip replacement
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System

Detailed Description:

This is a retrospective and prospective, non-randomized study of the Ceramic on Metal(CoM) device. This study will follow each subject through 10 years postoperatively. A total of 250 subjects will be enrolled in the investigation comprised of approximately 150 new PAS subjects and approximately 100 subjects recruited from the investigational device exemption study to the PAS.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. If the subject:

    1. Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
    2. Qualifies based on the approved labeling for the device; and
  • 2. Is willing and able to provide informed patient consent for participation in the PAS study; and
  • 3. Is willing and able to return for follow-up as specified by the PAS study protocol; and
  • 4. Is willing and able to complete the hip outcomes questionnaire as specified by the PAS study protocol. A patient will be considered a "Valid Study Subject" when he/she has

    • consented to participate,
    • authorized release of Personal Health Information (PHI),
    • met all eligibility criteria through the operative stage, and
    • received the implant as noted in this protocol.

Exclusion Criteria:

  • Subjects will be excluded if, in the opinion of the investigator, the subject does not qualify based on approved labeling requirements or Subject Inclusion criteria.
  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: NCT01543230

Locations
United States, Arkansas
Hip and Knee Arkansas Foundation
Little Rock, Arkansas, United States, 72205
United States, California
Orthopaedic Specialty Institute
Orange, California, United States, 92868
United States, Colorado
Ft. Collins, Colorado, United States, 80525
United States, North Carolina
Charlotte, North Carolina, United States, 28207
United States, Ohio
Cincinnati, Ohio, United States, 45236
United States, Washington
Seattle, Washington, United States, 98122
Sponsors and Collaborators
DePuy Orthopaedics
Investigators
Study Director: Dave Whalen, BS, DC DePuy Orthopaedics
  More Information

No publications provided

Responsible Party: DePuy Orthopaedics
ClinicalTrials.gov Identifier: NCT01543230     History of Changes
Other Study ID Numbers: 09014
Study First Received: February 27, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by DePuy Orthopaedics:
Non-Inflammatory Degenerative Joint Disease

Additional relevant MeSH terms:
Joint Diseases
Osteoarthritis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014