Status:
COMPLETED
Encore Revelation Hip Stem
Lead Sponsor:
Encore Medical, L.P.
Collaborating Sponsors:
DJO Incorporated
Conditions:
Osteoarthritis, Hip
Complications; Arthroplasty
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to obtain long-term (10+ yrs) clinical and patient outcomes data on patients who received the Revelation Hip Stem prior to 2002.
Eligibility Criteria
Inclusion
- Subjects must have received the Revelation™ Hip Stem as part of a total hip arthroplasty prior to 2002.
- Surgery must have been a primary total hip replacement
- Subject must have received only one primary hip replacement per hospitalization
- Subject must have had a diagnosis of inflammatory tissue disorder, osteoarthritis, post-traumatic arthritis/secondary arthritis or avascular necrosis
- Subject must be willing and able to sign the informed consent document
Exclusion
- Subject must not have had any previous hip implants (hemi or total joint)
- Subject has a mental condition that may interfere with the ability to give an informed consent (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
- Subject is a prisoner
- Subject is pregnant
Key Trial Info
Start Date :
February 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01514318
Start Date
February 1 2012
End Date
July 1 2012
Last Update
November 30 2012
Active Locations (1)
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1
Westlake Orthopaedics Spine & Sports
Austin, Texas, United States, 78746