Efficacy of the CLP® Hip - Retrospective

Encore Medical

Status: Terminated

Conditions: Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Treatments: Device: Encore CLP® Hip stem

Study type: Observational

Funder types: Industry

Identifiers

NCT00764842

PS - 802

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients must be 18 years of age or older.

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

1. Anyone who is under 18 years of age
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

Trial design

61 participants in 1 patient group

CLP Hip

Treatment:

Device: Encore CLP® Hip stem