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

NCT01754155 | Unknown

• 1 other identifier: CW55584
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Vitamin E; Zimmer; RSA; Radiostereometric Analysis

Outcome Measures

Primary Outcomes (7)

• Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt

  2 years

• Assessing the migration pattern of the Continuum® Cup

  2 years

• Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA

  2 years

• Determine if inducible displacement is indicative of adequate fixation

  2 years

• Assess the health status and functional outcome of patients with the Continuum® Cup

  2 years

• Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head

  2 years

• Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing

  2 years

Study Arms (1)

Vitamin E Polyethylene and RSA

OTHER

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

Interventions

RSA images RADIATION

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.

Vitamin E Polyethylene and RSA

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central DuPage Hospital: lead
• Zimmer Biomet: collaborator
• Halifax Biomedical Inc.: collaborator

Study Sites (1)

Central DuPage Hospital

Winfield, Illinois, 60190, United States

RECRUITING

Study Officials

• Scott Sporer, MD

  Central DuPage Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie Miller

CONTACT

630-933-6254; Stefanie.Miller@CadenceHealth.org

Judy Guerreiro

CONTACT

630-933-2941; Judy.Guerreiro@CadenceHealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 21, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 24, 2017

Record last verified: 2017-08

Locations

US (1)