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

Central DuPage Hospital

Status: Unknown

Conditions: Vitamin E Liner; Zimmer® Continuum® Acetabular Cup; Radiostereometric Analysis

Treatments: Radiation: RSA images

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01754155

CW55584

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Vitamin E Polyethylene and RSA

Other group

Description:

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.

Treatment:

Radiation: RSA images