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

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.

Study Overview

• Status: Unknown
• Conditions: Radiostereometric Analysis; Vitamin E Liner; Zimmer® Continuum® Acetabular Cup
• Intervention / Treatment: Radiation: RSA images

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefanie Miller; Phone Number: 630-933-6254; Email: Stefanie.Miller@CadenceHealth.org
• Study Contact Backup: Name: Judy Guerreiro; Phone Number: 630-933-2941; Email: Judy.Guerreiro@CadenceHealth.org

Study Locations

• United States
  • Illinois
    • Winfield, Illinois, United States, 60190
      • Recruiting
      • Central DuPage Hospital
      • Contact: Miller; Phone Number: 630-933-6254

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Central DuPage Hospital
• Collaborators: Zimmer Biomet; Halifax Biomedical Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: December 18, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (ESTIMATE): December 21, 2012

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Vitamin E; RSA; Radiostereometric Analysis; Zimmer
• Other Study ID Numbers: CW55584