CoMplete™ Acetabular Hip System
This study is enrolling participants by invitation only.
Sponsor:
DePuy Orthopaedics
Information provided by (Responsible Party):
DePuy Orthopaedics
ClinicalTrials.gov Identifier:
NCT01543230
First received: February 27, 2012
Last updated: June 1, 2012
Last verified: March 2012
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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 | Phase |
|---|---|---|
|
Joint Disease |
Device: Total hip replacement |
Phase 4 |
| 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).
| Estimated Enrollment: | 250 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | February 2022 |
| Estimated Primary Completion Date: | February 2022 (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:
- 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.
Contacts and Locations
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 | |
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: | June 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by DePuy Orthopaedics:
|
Non-Inflammatory Degenerative Joint Disease |
Additional relevant MeSH terms:
|
Joint Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013