Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
58 participants
INTERVENTIONAL
2012-02-29
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CoMplete™ Acetabular Hip System (CoM)
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Total hip replacement
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Interventions
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Total hip replacement
Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
Eligibility Criteria
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Inclusion Criteria
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.
21 Years
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Dave Whalen, BS, DC
Role: STUDY_DIRECTOR
DePuy Orthopaedics
Locations
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Hip and Knee Arkansas Foundation
Little Rock, Arkansas, United States
Orthopaedic Specialty Institute
Orange, California, United States
Fort Collins, Colorado, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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09014
Identifier Type: -
Identifier Source: org_study_id
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