NCT00764842
Terminated
Not Applicable
Post-Market Study: The Efficacy of the CLP® Hip
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Encore Medical, L.P.
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- The survivorship and efficacy of the Encore CLP® Hip stem
- Status
- Terminated
- Last Updated
- 15 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
The survivorship and efficacy of the Encore CLP® Hip stem
Time Frame: 2 year
Study Sites (1)
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