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A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene

NCT01754155 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2017-08-24

No results posted yet for this study

Summary

The purpose of this study is to use Radiostereometric Analysis (RSA) and clinical outcome measures to evaluate early, post-operative implant stability, post-operative implant fixation, clinical performance, and in-vivo wear of the Zimmer® Continuum® Cup with vitamin E stabilized polyethylene.

Conditions

  • Radiostereometric Analysis
  • Vitamin E Liner
  • Zimmer® Continuum® Acetabular Cup

Interventions

RADIATION

RSA images

All subjects will have the Vitamin E polyethylene and RSA beads placed during surgery. Subjects will then have standard x-ray images and RSA images taken at specific time points up until 2 years post-operatively.

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Halifax Biomedical Inc.

    collaborator INDUSTRY

  • Central DuPage Hospital

    lead OTHER

Principal Investigators

  • Scott Sporer, MD · Central DuPage Hospital

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2017-12-31
Completion
2018-12-31

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 NCT01754155 on ClinicalTrials.gov