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
185 participants
OBSERVATIONAL
2012-05-01
2019-09-24
Brief Summary
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In Phase One (0-5 years), diagnostic, demographic and operative information will be gathered for each subject enrolled in this study. In addition, Harris Hip Evaluations, subjective evaluations and radiographs will be completed annually.
In Phase Two (6 - 10 years), a subjective outcomes questionnaire and a SF-12 Health Survey will be mailed to subjects annually.
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Detailed Description
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1. a clinical follow-up phase and
2. a clinical outcomes phase.
Radiographic and clinical follow-up exams will take place at six-weeks, six-months and then annually through year 5 for each subject. For years 6 - 10, a communication will be sent to each subject in order to collect survivorship and general health information. This communication will ask whether the COC device is still in vivo and, if not, when the revision surgery took place, why, and which components were removed, if applicable. In addition, subjects will be asked to complete a SF-12 Health Survey at each 6 to 10-year follow-up interval. A self-addressed, stamped envelope will be provided to facilitate information return and privacy.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ceramax COC 28mm Acetabular Cup
The 28 mm ceramic acetabular bearing insert component is manufactured from high purity, dense alumina matrix composite ceramic. The inserts secure to DePuy's Pinnacle acetabular shells by means of an interlocking mechanical taper. The Pinnacle acetabular shell is a hemispherical type acetabulum replacement prosthesis, is available in a range of outer diameter (OD) sizes, and is used with a 28mm femoral head. Pinnacle 100 shells will be used in this study. The BIOLOX® delta ceramic femoral head components are manufactured from the same ceramic material as the acetabular bearing insert components. The femoral head is secured to the femoral stem component with an interlocking taper.
Ceramax Acetabular System
28mm Ceramic-on-ceramic Acetabular Cup System
Interventions
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Ceramax Acetabular System
28mm Ceramic-on-ceramic Acetabular Cup System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly recruited individuals who are qualified based on the approved labeling of the device, and;
* Individuals who are willing and able to provide informed patient consent for participation in the study;
* Individuals who are willing and able to return for follow-up as specified by the study protocol; and
* Individuals who are willing and able to complete the Hip Outcomes questionnaire and SF-12 Health Survey as specified by the study protocol
Exclusion Criteria
ALL
No
Sponsors
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DePuy Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Tammy L ODell, BS CCRC CCRA
Role: STUDY_DIRECTOR
DePuy Orthopaedics
Locations
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Joint Surgeons of Sacremento
Sacramento, California, United States
Colorado Joint Replacement
Denver, Colorado, United States
Fort Collins, Colorado, United States
Florida University
Gainesville, Florida, United States
FOI Florida Orthopaedic Institute
Tampa, Florida, United States
New England Baptist Hospital
Boston, Massachusetts, United States
Tufts - New England Medical Center
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
OrthoCarolina
Winston-Salem, North Carolina, United States
Cardinal Orthopaedic Institute
Columbus, Ohio, United States
UPenn
Philadelphia, Pennsylvania, United States
Anderson Orthopaedic Research Institute
Alexandria, Virginia, United States
McGill University - Jewish General Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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09001
Identifier Type: -
Identifier Source: org_study_id
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