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

This study is currently recruiting participants.
Verified April 2013 by Central DuPage Hospital
Sponsor:
Collaborators:
Zimmer, Inc.
Halifax Biomedical Inc
Information provided by (Responsible Party):
Central DuPage Hospital
ClinicalTrials.gov Identifier:
NCT01754155
First received: December 18, 2012
Last updated: April 9, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Radiostereometric Analysis
Vitamin E Liner
Zimmer® Continuum® Acetabular Cup
Radiation: RSA images

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Prospective Radiostereometric Analysis and Clinical Evaluation of the Zimmer® Continuum® Acetabular Cup With Vitamin E Stabilized Polyethylene

Resource links provided by NLM:


Further study details as provided by Central DuPage Hospital:

Primary Outcome Measures:
  • Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assessing the migration pattern of the Continuum® Cup [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determine if inducible displacement is indicative of adequate fixation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess the health status and functional outcome of patients with the Continuum® Cup [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vitamin E Polyethylene and RSA
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic osteoarthritis of the hip indicating surgical intervention
  • Scheduled to undergo an uncemented total hip arthroplasty (THA)
  • Patients between the ages of 18 and 65, inclusive
  • Ability to give informed consent
  • Patients will be available for follow-up for a minimum of 2 years after surgery

Exclusion Criteria:

  • Patients less than 18 years of age, or older than 65 years of age.
  • Post-traumatic arthritis in the affected hip
  • Rheumatoid arthritis in the affected hip
  • Hip dysplasia in the affected hip
  • Prior arthroplasty of the affected hip
  • Active or prior infection of the affected hip
  • Morbid obesity (BMI > 35)
  • Medical condition precluding major surgery
  • Severe osteoporosis or osteopenia
  • Neuromuscular impairment
  • Patients with known allergy to metals
  • Pregnancy
  • Patients with compromised kidney function
  • Patient is immuno-suppressed
  • Patients that require a femoral head less than 32 mm or greater than 40mm.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754155

Contacts
Contact: Stefanie Miller 630-933-6254 Stefanie.Miller@CadenceHealth.org
Contact: Judy Guerreiro 630-933-2941 Judy.Guerreiro@CadenceHealth.org

Locations
United States, Illinois
Central DuPage Hospital Recruiting
Winfield, Illinois, United States, 60190
Contact: Miller    630-933-6254      
Principal Investigator: Scott Sporer, MD         
Sponsors and Collaborators
Central DuPage Hospital
Zimmer, Inc.
Halifax Biomedical Inc
Investigators
Principal Investigator: Scott Sporer, MD Central DuPage Hospital
  More Information

No publications provided

Responsible Party: Central DuPage Hospital
ClinicalTrials.gov Identifier: NCT01754155     History of Changes
Other Study ID Numbers: CW55584
Study First Received: December 18, 2012
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Central DuPage Hospital:
Vitamin E
Zimmer
RSA
Radiostereometric Analysis

Additional relevant MeSH terms:
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 17, 2014