Study Stopped
Sponsor withdrew PMA
CoMplete™ Acetabular Hip System
Ceramic on Metal Total Hip System, CoMplete™ Acetabular Hip System
1 other identifier
interventional
58
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2012
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 27, 2012
CompletedFirst Posted
Study publicly available on registry
March 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedApril 8, 2014
April 1, 2014
1.7 years
February 27, 2012
April 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
10 years
Secondary Outcomes (1)
Metal Ion Levels
5 years, 8 years, and 10 years postoperatively
Study Arms (1)
CoMplete™ Acetabular Hip System (CoM)
EXPERIMENTALTotal hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Interventions
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Eligibility Criteria
You may qualify if:
- \. 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
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hip and Knee Arkansas Foundation
Little Rock, Arkansas, 72205, United States
Orthopaedic Specialty Institute
Orange, California, 92868, United States
Unknown Facility
Fort Collins, Colorado, 80525, United States
Unknown Facility
Charlotte, North Carolina, 28207, United States
Unknown Facility
Cincinnati, Ohio, 45236, United States
Unknown Facility
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dave Whalen, BS, DC
DePuy Orthopaedics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2012
First Posted
March 2, 2012
Study Start
February 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
April 8, 2014
Record last verified: 2014-04