Trial record 2 of 87 for:    CONTINUUM

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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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:
Vitamins
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on October 19, 2014