Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA

Mass General Brigham

Status

Unknown

Conditions

Osteoarthritis of Hip

Traumatic Arthritis of Hip

Treatments

Procedure: Hip replacement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00551967

2007P000337

Details and patient eligibility

About

The specific aim of this proposed study is to conduct a prospective RSA clinical study at Massachusetts General Hospital involving 50 patients receiving primary total hip replacements. All patients will receive the vitamin E treated polyethylene acetabular inserts. Short-term femoral head penetration and long-term steady state wear of the polyethylene will be measured using both RSA and Martell analysis techniques. Stability of the acetabular and femoral components will be measured in all patients using RSA analysis. The stability of the cemented femoral stems will be compared to the stability of the cementless femoral components as well as to historic data in the literature. In addition, all patients will complete a self-administered questionnaire to assess the clinical outcome of the surgery and patient satisfaction.

Enrollment

50 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female
20 to 75 years of age
Subjects requiring primary total hip replacement
Subjects with diagnosis of osteoarthritis, avascular necrosis, or traumatic arthritis
Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

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 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 techniques 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.