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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01754155
Recruitment Status : Unknown
Verified August 2017 by Central DuPage Hospital.
Recruitment status was:  Recruiting
First Posted : December 21, 2012
Last Update Posted : August 24, 2017
Sponsor:
Collaborators:
Zimmer Biomet
Halifax Biomedical Inc.
Information provided by (Responsible Party):
Central DuPage Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Radiostereometric Analysis Vitamin E Liner Zimmer® Continuum® Acetabular Cup Radiation: RSA images Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin E

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt [ Time Frame: 2 years ]
  2. Assessing the migration pattern of the Continuum® Cup [ Time Frame: 2 years ]
  3. Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA [ Time Frame: 2 years ]
  4. Determine if inducible displacement is indicative of adequate fixation [ Time Frame: 2 years ]
  5. Assess the health status and functional outcome of patients with the Continuum® Cup [ Time Frame: 2 years ]
  6. Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head [ Time Frame: 2 years ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754155


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

Locations
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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 Biomet
Halifax Biomedical Inc.
Investigators
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Principal Investigator: Scott Sporer, MD Central DuPage Hospital
More Information
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Responsible Party: Central DuPage Hospital
ClinicalTrials.gov Identifier: NCT01754155    
Other Study ID Numbers: CW55584
First Posted: December 21, 2012    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Keywords provided by Central DuPage Hospital:
Vitamin E
Zimmer
RSA
Radiostereometric Analysis