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

Not Applicable

• Conditions: Vitamin E Liner; Radiostereometric Analysis; Zimmer® Continuum® Acetabular Cup
• Interventions: Radiation: RSA images

• Registration Number: NCT01754155
• Lead Sponsor: Central DuPage Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-18
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Study Start: 2013-01
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-23
• Last Update Posted: 2017-08-24
• Primary Completion: 2017-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin E Polyethylene and RSA	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.

Primary Outcome Measures

Name	Time	Method
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
Determining a correlation between radiolucent lines (RLLs) measured by Charnley-DeLee Zone Analyses and migration characteristics using RSA	2 years
Assessing the Continuum® Cup for adequate fixation to the underlying bone as measured by migration and tilt	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
Assessing the migration pattern of the Continuum® Cup	2 years

Trial Locations

Locations (1)

Central DuPage Hospital; 🇺🇸 Winfield, Illinois, United States