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

Primary Purpose

Osteoarthritis of Hip, Traumatic Arthritis of Hip

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hip replacement
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of Hip focused on measuring clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

E1 polyethylene

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2007
Last Updated
May 2, 2017
Sponsor
Massachusetts General Hospital
Collaborators
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT00551967
Brief Title
Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA
Official Title
Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary Total Hip Arthroplasty Using Radiostereometric Analysis (RSA)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Zimmer Biomet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip, Traumatic Arthritis of Hip
Keywords
clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E1 polyethylene
Arm Type
Active Comparator
Arm Description
All patients received an E1 polyethylene liner which is the material being monitored in this study.
Intervention Type
Procedure
Intervention Name(s)
Hip replacement
Intervention Description
Surgical implantation of hip replacement components for the treatment of osteoarthritis
Primary Outcome Measure Information:
Title
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.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henrik Malchau, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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