Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA

NCT ID: NCT00551967

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2022-12-31

Brief Summary

The specific aim of this proposed study is to conduct a prospective RSA clinical study at Massachusetts General Hospital involving 50 patients receiving primary total hip replacements. All patients will receive the vitamin E treated polyethylene acetabular inserts. Short-term femoral head penetration and long-term steady state wear of the polyethylene will be measured using both RSA and Martell analysis techniques. Stability of the acetabular and femoral components will be measured in all patients using RSA analysis. The stability of the cemented femoral stems will be compared to the stability of the cementless femoral components as well as to historic data in the literature. In addition, all patients will complete a self-administered questionnaire to assess the clinical outcome of the surgery and patient satisfaction.

Conditions

Osteoarthritis of Hip; Traumatic Arthritis of Hip

Study Design

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

Study Groups

E1 polyethylene

All patients received an E1 polyethylene liner which is the material being monitored in this study.

Group Type: ACTIVE_COMPARATOR

Hip replacement

Intervention Type: PROCEDURE

Surgical implantation of hip replacement components for the treatment of osteoarthritis

Interventions

Hip replacement

Surgical implantation of hip replacement components for the treatment of osteoarthritis

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male or female
• 20 to 75 years of age
• Subjects requiring primary total hip replacement
• Subjects with diagnosis of osteoarthritis, avascular necrosis, or traumatic arthritis
• Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

Exclusion Criteria

• Subjects with limited life span
• Subjects with difficulty in comprehending study protocol for any reason.
• Subjects with inflammatory disease, previous infection or those requiring revision hip surgery.
• Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.
• Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia
• Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity.
• Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Henrik Malchau

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Henrik Malchau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2007P000337

Identifier Type: -

Identifier Source: org_study_id