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Efficacy of the CLP® Hip - Retrospective

This study has been terminated.
(Enrollment and data collection insufficient to continue study.)
Sponsor:
Information provided by:
Encore Medical, L.P.
ClinicalTrials.gov Identifier:
NCT00764842
First received: September 30, 2008
Last updated: February 8, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
 Device: Encore CLP® Hip stem
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-Market Study: The Efficacy of the CLP® Hip

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Encore Medical, L.P.:

Primary Outcome Measures:
  • The survivorship and efficacy of the Encore CLP® Hip stem [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: January 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764842

Locations
United States, California
Center for Excellence
Fresno, California, United States, 93710
Sponsors and Collaborators
Encore Medical, L.P.
Investigators
Principal Investigator: D. Kevin Lester, M.D. Center for Excellence
  More Information

Additional Information:
Sponsor company home page  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jane M. Jacob Ph.D., DJO Surgical
ClinicalTrials.gov Identifier: NCT00764842     History of Changes
Other Study ID Numbers: PS - 802
Study First Received: September 30, 2008
Last Updated: February 8, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Necrosis
Osteonecrosis
Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Bone Diseases

ClinicalTrials.gov processed this record on May 21, 2013