Stuart Goodman
Evaluation of E-Poly (tm) and Regenerex (tm) Cementless Acetabular Components: Clinical and Radiographic Outcomes
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
The purpose of this investigation is to document the long term (10-year) radiographic and clinical outcomes of a new type of highly cross-linked polyethylene liner (E-Poly) and acetabular component (Regenerex) in a group of primary total hip arthroplasty patients.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: E-Poly (tm) Liner
Phase:
Phase 4Eligibility
Ages Eligible for Study:
20 years to 75 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
Subjects requiring primary total hip replacement. Subjects with diagnosis of osteoarthritis, or traumatic arthritis. Subjects with the appropriate bone stock to accept an acetabular component with a 32mm inner diameter. Subjects who demonstrate the ability to return for follow-up for the next ten years.
Key Exclusion Criteria:
Subjects with limited life span. Subjects with difficulty in comprehending study protocol for any reason. Subjects with inflammatory disease, previous infection or those requiring revision hip surgery. Subjects with avascular necrosis. Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used. Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard texhniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia. Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
Additional Study Details
Official Title:
Long-Term Multi-center Evaluation of E-Poly (tm) and Regenerex (tm) Cementless Acetabular Components: Clinical and Radiographic OutcomesAnticipated start date:
8/12/2008Lead Sponsor:
Biomet OrthopaedicsCollaborator(s):
- Massachusetts General Hospital
Investigator(s):
Study Type:
ObservationalPurpose:
NOTNEEDEDDuration:
LongitudinalSelection:
Defined PopulationTiming:
ProspectiveTotal Number to be Enrolled:
1000Total Number to be Enrolled at Stanford:
100More Information
Secondary ID(s):
- 15009
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
7/27/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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