Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA
Verified September 2014 by Massachusetts General Hospital
Information provided by (Responsible Party):
Henrik Malchau, Massachusetts General Hospital
First received: October 30, 2007
Last updated: September 24, 2014
Last verified: September 2014
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.
Osteoarthritis of Hip
Traumatic Arthritis of Hip
Procedure: Hip replacement
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary Total Hip Arthroplasty Using Radiostereometric Analysis (RSA)
Primary Outcome Measures:
- Short-term femoral head penetration,long-term steady state wear of polyethylene. Stability of acetabular & femoral components. Clinical questionnaires to assess preop,clinical outcomes,& patient satisfaction. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2022 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||20 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00551967
Massachusetts General Hospital
||Henrik Malchau, MD, PhD
||Massachusetts General Hospital
No publications provided
||Henrik Malchau, Director of Research, Massachusetts General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 30, 2007
||September 24, 2014
||United States: Institutional Review Board
Keywords provided by Massachusetts General Hospital:
total hip arthroplasty
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 26, 2015