Recruiting

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

Sponsor:

Central DuPage Hospital

Code:

NCT01754155

Conditions

Radiostereometric Analysis

Vitamin E Liner

Zimmer® Continuum® Acetabular Cup

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

RSA images

Study Details

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

Study ID

NCT01754155

Start date

Jan, 2013

Status verified date

Aug, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

RSA images

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Stefanie Miller

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

Judy Guerreiro

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

Locations

Central DuPage Hospital

Recruiting

Winfield, Illinois, United States, 60190

Contacts

Miller

630-933-6254

Principal Investigator:

Scott Sporer, MD

More Information

Sponsor

Central DuPage Hospital

Last update posted

Aug 24, 2017

Last verified

Aug, 2017

Keywords

Vitamin E
Zimmer
RSA
Radiostereometric Analysis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Central DuPage Hospital on 2017-08-24.