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

NCT ID: NCT01754155

Last Updated: 2017-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2018-12-31

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

RSA images

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Halifax Biomedical Inc.

INDUSTRY

Sponsor Role: collaborator

Central DuPage Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Sporer, MD

Role: PRINCIPAL_INVESTIGATOR

Central DuPage Hospital

Locations

Central DuPage Hospital

Winfield, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stefanie Miller

Role: CONTACT

Stefanie.Miller@CadenceHealth.org

630-933-6254

Judy Guerreiro

Role: CONTACT

Judy.Guerreiro@CadenceHealth.org

630-933-2941

Facility Contacts

Miller

Role: primary

630-933-6254

Other Identifiers

CW55584

Identifier Type: -

Identifier Source: org_study_id