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

NCT00551967 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-05-03

No results posted yet for this study

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.

Conditions

  • Osteoarthritis of Hip
  • Traumatic Arthritis of Hip

Interventions

PROCEDURE

Hip replacement

Surgical implantation of hip replacement components for the treatment of osteoarthritis

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

  • Zimmer Biomet

    collaborator INDUSTRY

Principal Investigators

  • Henrik Malchau, MD, PhD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00551967 on ClinicalTrials.gov