Back to resultsCoMplete™ Acetabular Hip System
Primary Purpose
Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Post-traumatic Arthritis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Total hip replacement
Sponsored by
About this trial
This is an interventional treatment trial for Non-inflammatory Degenerative Joint Disease focused on measuring Non-Inflammatory Degenerative Joint Disease
Eligibility Criteria
Inclusion Criteria:
1. If the subject:
- Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
- 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.
Sites / Locations
- Hip and Knee Arkansas Foundation
- Orthopaedic Specialty Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CoMplete™ Acetabular Hip System (CoM)
Arm Description
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Outcomes
Primary Outcome Measures
Survivorship
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01543230
Brief Title
CoMplete™ Acetabular Hip System
Official Title
Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Sponsor withdrew PMA
Study Start Date
February 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Orthopaedics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Post-traumatic Arthritis
Keywords
Non-Inflammatory Degenerative Joint Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CoMplete™ Acetabular Hip System (CoM)
Arm Type
Experimental
Arm Description
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Intervention Type
Device
Intervention Name(s)
Total hip replacement
Intervention Description
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Primary Outcome Measure Information:
Title
Survivorship
Description
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).
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Metal Ion Levels
Description
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.
Time Frame
5 years, 8 years, and 10 years postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. If the subject:
Was previously enrolled in the CoM IDE study with the Ceramic-on- Metal device, or
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Whalen, BS, DC
Organizational Affiliation
DePuy Orthopaedics
Official's Role
Study Director
Facility Information:
Facility Name
Hip and Knee Arkansas Foundation
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Orthopaedic Specialty Institute
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
City
Ft. Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
12. IPD Sharing Statement
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CoMplete™ Acetabular Hip System
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