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

This study is currently recruiting participants.

Verified by Massachusetts General Hospital, March 2008

First Received: October 30, 2007 Last Updated: March 4, 2008 History of Changes

Sponsors and Collaborators:	Massachusetts General Hospital Biomet, Inc.
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00551967

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

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Vitamin E

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Single Group Assignment, Treatment, Uncontrolled
Official Title:	Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary Total Hip Arthroplasty Using Radiostereometric Analysis (RSA)

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:

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

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:	Massachusetts General Hospital ( Henrik Malchau, MD, PhD )
Study ID Numbers:	2007P000337
Study First Received:	October 30, 2007
Last Updated:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00551967 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

clinical outcomes
radiographic outcomes
survivorship
total hip arthroplasty

Study placed in the following topic categories:

Tocopherols
Tocopherol acetate
Vitamin E
Musculoskeletal Diseases
Osteoarthritis
Vitamins

Joint Diseases
Arthritis
Tocotrienols
Rheumatic Diseases
Osteoarthritis, Hip
Alpha-Tocopherol

Additional relevant MeSH terms:

Osteoarthritis, Hip
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on March 16, 2009