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
61 participants
OBSERVATIONAL
2008-01-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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CLP Hip
Encore CLP® Hip stem
Subjects with osteoarthritis, rheumatoid arthritis or avascular necrosis of the natural femoral head who have received the Encore CLP® Hip stem and are willing to participate in the study.
Interventions
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Encore CLP® Hip stem
Subjects with osteoarthritis, rheumatoid arthritis or avascular necrosis of the natural femoral head who have received the Encore CLP® Hip stem and are willing to participate in the study.
Eligibility Criteria
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Inclusion Criteria
2. Noninflammatory degenerative joint disease including
* Osteoarthritis of the natural femoral head
* Avascular necrosis of the natural femoral head
* Rheumatoid arthritis
3. Correction of functional deformities
4. Femoral fracture
5. Patients must be able and willing to complete all study-related visits.
Exclusion Criteria
2. Infection or sepsis
3. Insufficient bone quality which may affect the stability of the implant
4. Muscular, neurological or vascular deficiencies, which compromise the affected extremity
5. Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around hip joint which would make the procedure unjustifiable
6. Osteomyelitis
7. Rapid joint destruction or bone absorption apparent on roentgenogram
8. Pathological conditions of the acetabulum which would prevent achieving proper range of motion, appropriate head stability, and/or a well-seated and supported smooth articulation of the head within the acetabulum
9. Alcoholism or other addictions
10. Materials sensitivity
11. Loss of ligamentous structures
12. High levels of physical activity (e.g., competitive sports, heavy physical labor)
13. Pregnancy
18 Years
ALL
No
Sponsors
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Encore Medical, L.P.
INDUSTRY
Responsible Party
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DJO Surgical
Principal Investigators
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D. Kevin Lester, M.D.
Role: PRINCIPAL_INVESTIGATOR
Center for Excellence
Locations
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Center for Excellence
Fresno, California, United States
Countries
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Related Links
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Sponsor company home page
Other Identifiers
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PS - 802
Identifier Type: -
Identifier Source: org_study_id
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