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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00551967
Recruitment Status : Active, not recruiting
First Posted : November 1, 2007
Last Update Posted : May 3, 2017
Zimmer Biomet
Information provided by (Responsible Party):
Henrik Malchau, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Hip Traumatic Arthritis of Hip Procedure: Hip replacement Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary Total Hip Arthroplasty Using Radiostereometric Analysis (RSA)
Study Start Date : October 2007
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: E1 polyethylene
All patients received an E1 polyethylene liner which is the material being monitored in this study.
Procedure: Hip replacement
Surgical implantation of hip replacement components for the treatment of osteoarthritis

Primary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00551967

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Zimmer Biomet
Principal Investigator: Henrik Malchau, MD, PhD Massachusetts General Hospital

Responsible Party: Henrik Malchau, Director of Research, Massachusetts General Hospital Identifier: NCT00551967     History of Changes
Other Study ID Numbers: 2007P000337
First Posted: November 1, 2007    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017

Keywords provided by Henrik Malchau, Massachusetts General Hospital:
clinical outcomes
radiographic outcomes
total hip arthroplasty

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Vitamin E
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances