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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Massachusetts General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Biomet, Inc.
Information provided by (Responsible Party):
Henrik Malchau, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00551967
First received: October 30, 2007
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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 Intervention
Osteoarthritis of Hip
Traumatic Arthritis of Hip
Procedure: Hip replacement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

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: 50
Study Start Date: October 2007
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Hip replacement
    Surgical implantation of hip replacement components for the treatment of osteoarthritis
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551967

Contacts
Contact: Henrik Malchau, MD, PhD 617-726-3866 hmalchau@partners.org
Contact: Charles R Bragdon, PhD 617-724-7544 cbragdon@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Henrik Malchau, MD, PhD    617-726-3866    hmalchau@partners.org   
Contact: Charles R Bragdon, PhD    617-724-7544    cbragdon@partners.org   
Sponsors and Collaborators
Massachusetts General Hospital
Biomet, Inc.
Investigators
Principal Investigator: Henrik Malchau, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Henrik Malchau, Director of Research, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00551967     History of Changes
Other Study ID Numbers: 2007P000337
Study First Received: October 30, 2007
Last Updated: August 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
clinical outcomes
radiographic outcomes
total hip arthroplasty
survivorship

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014