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

Radiostereometric Analysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01754155
• Other study ID #: CW55584
• Status: Recruiting
• Phase: N/A
• First received: December 18, 2012
• Last updated: August 23, 2017
• Start date: January 2013
• Est. completion date: December 2018

Study information

• Verified date: August 2017
• Source: Central DuPage Hospital
• Contact: Stefanie Miller
• Phone: 630-933-6254
• Email: Stefanie.Miller[@]CadenceHealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Central DuPage Hospital	Winfield	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Central DuPage Hospital	Halifax Biomedical Inc., Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt		2 years
Primary	Assessing the migration pattern of the Continuum® Cup		2 years
Primary	Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA		2 years
Primary	Determine if inducible displacement is indicative of adequate fixation		2 years
Primary	Assess the health status and functional outcome of patients with the Continuum® Cup		2 years
Primary	Assess the wear rate of the Vitamin E polyethylene with a ceramic femoral head		2 years
Primary	Determine if the wear rate of the Vitamin E liner is the same in-vivo as it is in simulation testing		2 years