Efficacy of the CLP® Hip - Retrospective

Rheumatoid Arthritis Clinical Trial

Official title:

Post-Market Study: The Efficacy of the CLP® Hip

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00764842
• Other study ID #: PS - 802
• Status: Terminated
• Phase: Phase 4
• First received: September 30, 2008
• Last updated: February 8, 2011
• Start date: January 2008
• Est. completion date: February 2011

Study information

• Verified date: February 2011
• Source: Encore Medical, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 61
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Avascular Necrosis
• Osteoarthritis
• Rheumatoid Arthritis

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Center for Excellence	Fresno	California

Sponsors (1)

Lead Sponsor	Collaborator
Encore Medical, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The survivorship and efficacy of the Encore CLP® Hip stem		2 year	No

External Links

•   Sponsor company home page