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Efficacy of the CLP® Hip - Retrospective

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00764842
Recruitment Status : Terminated (Enrollment and data collection insufficient to continue study.)
First Posted : October 2, 2008
Last Update Posted : February 9, 2011
Information provided by:
Encore Medical, L.P.

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.

Condition or disease Intervention/treatment
Osteoarthritis Avascular Necrosis Rheumatoid Arthritis Device: Encore CLP® Hip stem

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-Market Study: The Efficacy of the CLP® Hip
Study Start Date : January 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
CLP Hip 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.

Primary Outcome Measures :
  1. The survivorship and efficacy of the Encore CLP® Hip stem [ Time Frame: 2 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals who meet the indications for use of the CLP Hip Stem AND who meet the inclusion/exclusion criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00764842

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United States, California
Center for Excellence
Fresno, California, United States, 93710
Sponsors and Collaborators
Encore Medical, L.P.
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Principal Investigator: D. Kevin Lester, M.D. Center for Excellence
Additional Information:
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Responsible Party: Jane M. Jacob Ph.D., DJO Surgical Identifier: NCT00764842    
Other Study ID Numbers: PS - 802
First Posted: October 2, 2008    Key Record Dates
Last Update Posted: February 9, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
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Pathologic Processes