In This SectionTexas Health Research & Education Institute
Disease or Condition
Osteoarthritis / Hip Replacement
Long term evaluation of E-poly ™ cementless acetabular components (Orthopedics / Hip Replacement)
Long-Term Multi-Center Evaluation of E-Poly™ and Regenerex™ Cementless Acetabular Components: Clinical and Radiographic Outcomes.
Male or Female.
20 to 75 years of age.
Subjects with diagnosis of osteoarthritis, or traumatic arthritis.
Subjects with the appropriate bone stock to accept an acetabular componet with a 32 mm inner diameter.
Subject requiring primary total hip replacement6. Subjects who demonstrate the ability to return for follow-up care for the next 10 years.
Subjects with limited life span.
Subjects with difficulty in comprehending study protocol for any reason.
Subjects with inflamatory disease, previous inection or those requiring revision hip surgery.
Subjects with avascualr necrosis.
Subjects whose boney structure are so small that a femoral head less than 32mm in diameter must be used.
Subjects whose boney structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of theses are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia.
Subjects with complex disease entities which signfigantly 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.