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TerminatedNCT00764842Updated Feb 9, 2011

Efficacy of the CLP® Hip - Retrospective

An observational study in Osteoarthritis, Avascular Necrosis and Rheumatoid Arthritis, sponsored by Encore Medical, L.P.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-09.

Sponsored by Encore Medical, L.P. · Observational

Why this study was terminated
Enrollment and data collection insufficient to continue study.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
61
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Osteoarthritis
  • Avascular Necrosis
  • Rheumatoid Arthritis

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03

In context

Necrosis

477 studies on the registry are indexed under Necrosis; 54 are open to participants now.

This study's enrollment of 61 is below the median of 100 across 147 observational studies indexed under Necrosis.

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Lead sponsor

Encore Medical, L.P. is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
61 participants (actual)

Groups and cohorts

  • CLP Hip

    Device: Encore CLP® Hip stem

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.

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What researchers measure

Primary outcomes

  1. The survivorship and efficacy of the Encore CLP® Hip stem

    Time frame: 2 year

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Study locations

1 site
  • Center for Excellence
    Fresno, California 93710, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00764842
Lead sponsor
Encore Medical, L.P.
First posted
Oct 2, 2008
Start date
Jan 2008
Primary completion
Feb 2011
Completion
Feb 2011
Last update
Feb 9, 2011

Study contacts

D. Kevin Lester, M.D.
principal investigator · Center for Excellence

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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