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Efficacy of the CLP® Hip - Retrospective

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00764842
Enrollment
61
Registered
2008-10-02
Start date
2008-01-31
Completion date
2011-02-28
Last updated
2011-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular Necrosis, Osteoarthritis, Rheumatoid Arthritis

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.

Interventions

DEVICEEncore 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.

Sponsors

Encore Medical, L.P.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The survivorship and efficacy of the Encore CLP® Hip stem2 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026