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

Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary Total Hip Arthroplasty Using Radiostereometric Analysis (RSA)

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis of Hip; Traumatic Arthritis of Hip
• Intervention / Treatment: Procedure: Hip replacement

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: E1 polyethylene; All patients received an E1 polyethylene liner which is the material being monitored in this study.	Procedure: Hip replacement; Surgical implantation of hip replacement components for the treatment of osteoarthritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Short-term femoral head penetration,long-term steady state wear of polyethylene. Stability of acetabular & femoral components. Clinical questionnaires to assess preop,clinical outcomes,& patient satisfaction.	5 years

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Zimmer Biomet
• Investigators: Principal Investigator: Henrik Malchau, MD, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 30, 2007
• First Submitted That Met QC Criteria: October 30, 2007
• First Posted (Estimate): November 1, 2007

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: total hip arthroplasty; survivorship; clinical outcomes; radiographic outcomes
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: 2007P000337