CoMplete™ Acetabular Hip System
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Survivorship [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
- Metal Ion Levels [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
- 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
-
- Is willing and able to provide informed patient consent for participation in the PAS study; and
-
- Is willing and able to return for follow-up as specified by the PAS study protocol; and
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- 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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hip and Knee Arkansas Foundation | Little Rock | Arkansas | United States | 72205 |
| 2 | Orthopaedic Specialty Institute | Orange | California | United States | 92868 |
| 3 | Ft. Collins | Colorado | United States | 80525 | |
| 4 | Charlotte | North Carolina | United States | 28207 | |
| 5 | Cincinnati | Ohio | United States | 45236 | |
| 6 | Seattle | Washington | United States | 98122 |
Sponsors and Collaborators
- DePuy Orthopaedics
Investigators
- Study Director: Dave Whalen, BS, DC, DePuy Orthopaedics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 09014