CoMplete™ Acetabular Hip System

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. Identifier: NCT01543230
Recruitment Status : Terminated (Sponsor withdrew PMA)
First Posted : March 2, 2012
Last Update Posted : April 8, 2014
Information provided by (Responsible Party):
DePuy Orthopaedics

Brief Summary:
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 or disease Intervention/treatment Phase
Non-inflammatory Degenerative Joint Disease Osteoarthritis Post-traumatic Arthritis Device: Total hip replacement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Survivorship [ Time Frame: 10 years ]
    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 :
  1. Metal Ion Levels [ Time Frame: 5 years, 8 years, and 10 years postoperatively ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01543230

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
Study Director: Dave Whalen, BS, DC DePuy Orthopaedics

Responsible Party: DePuy Orthopaedics Identifier: NCT01543230     History of Changes
Other Study ID Numbers: 09014
First Posted: March 2, 2012    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014

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

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases