Status:
TERMINATED
Efficacy of the CLP® Hip - Retrospective
Lead Sponsor:
Encore Medical, L.P.
Conditions:
Osteoarthritis
Avascular Necrosis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from whom data has already been collected.
Eligibility Criteria
Inclusion
- Patients must be 18 years of age or older.
- Noninflammatory degenerative joint disease including
- Osteoarthritis of the natural femoral head
- Avascular necrosis of the natural femoral head
- Rheumatoid arthritis
- Correction of functional deformities
- Femoral fracture
- Patients must be able and willing to complete all study-related visits.
Exclusion
- Anyone who is under 18 years of age
- Infection or sepsis
- Insufficient bone quality which may affect the stability of the implant
- Muscular, neurological or vascular deficiencies, which compromise the affected extremity
- 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
- Osteomyelitis
- Rapid joint destruction or bone absorption apparent on roentgenogram
- 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
- Alcoholism or other addictions
- Materials sensitivity
- Loss of ligamentous structures
- High levels of physical activity (e.g., competitive sports, heavy physical labor)
- Pregnancy
Key Trial Info
Start Date :
January 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00764842
Start Date
January 1 2008
End Date
February 1 2011
Last Update
February 9 2011
Active Locations (1)
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1
Center for Excellence
Fresno, California, United States, 93710