Efficacy of the CLP® Hip - Retrospective

NCT00764842 | Terminated

• 1 other identifier: PS - 802
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• The survivorship and efficacy of the Encore CLP® Hip stem

  2 year

Study Arms (1)

CLP Hip

Device: Encore CLP® Hip stem

Interventions

Encore CLP® Hip stem 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.

CLP Hip

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients must be 18 years of age or older.
• Noninflammatory degenerative joint disease including
• Osteoarthritis of the natural femoral head
• Avascular necrosis of the natural femoral head
• Rheumatoid arthritis
• Correction of functional deformities
• Femoral fracture
• Patients must be able and willing to complete all study-related visits.

You may not qualify if:

• Anyone who is under 18 years of age
• Infection or sepsis
• Insufficient bone quality which may affect the stability of the implant
• Muscular, neurological or vascular deficiencies, which compromise the affected extremity
• 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
• Osteomyelitis
• Rapid joint destruction or bone absorption apparent on roentgenogram
• 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
• Alcoholism or other addictions
• Materials sensitivity
• Loss of ligamentous structures
• High levels of physical activity (e.g., competitive sports, heavy physical labor)
• Pregnancy

Sponsors & Collaborators

• Encore Medical, L.P.: lead

Study Sites (1)

Center for Excellence

Fresno, California, 93710, United States

Location

Related Links

• Sponsor company home page

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• D. Kevin Lester, M.D.

  Center for Excellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: October 2, 2008
• Study Start: January 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 9, 2011

Record last verified: 2011-02

Locations

US (1)