Efficacy of the CLP® Hip - Retrospective

NCT ID: NCT00764842

Last Updated: 2011-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

61 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis Avascular Necrosis Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CLP Hip

Encore CLP® Hip stem

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Encore Medical, L.P.

INDUSTRY

Sponsor Role lead

Responsible Party

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DJO Surgical

Principal Investigators

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D. Kevin Lester, M.D.

Role: PRINCIPAL_INVESTIGATOR

Center for Excellence

Locations

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Center for Excellence

Fresno, California, United States

Site Status

Countries

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United States

Related Links

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http://www.djosurgical.com

Sponsor company home page

Other Identifiers

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PS - 802

Identifier Type: -

Identifier Source: org_study_id

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