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Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

Primary Purpose

Osteoarthritis of Hip, Failure of Primary THA

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bead placement during revision hip replacement surgery
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

25 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female.
  2. 25 to 75 years of age.
  3. Subjects requiring revision total hip replacement.
  4. Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

Exclusion Criteria:

  1. Subjects with limited life span.
  2. Subjects with difficulty in comprehending study protocol for any reason.
  3. Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection.

  4. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

    • A urine HCG will be done in all women of child bearing potential prior to RSA imaging at each follow-up visit. The result will be recorded in the research record.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Revision Total Hip

Arm Description

patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone.

Outcomes

Primary Outcome Measures

Stability of Acetabular and femoral components
RSA films will be taken at the prescribed time intervals to measure component mothion over time.

Secondary Outcome Measures

Wear of the polyethlene component
The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.

Full Information

First Posted
August 10, 2012
Last Updated
November 4, 2013
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01668160
Brief Title
Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis
Official Title
Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Study Start Date
February 2012 (undefined)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The specific aim is to quantify the stability of the acetabular and femoral components of a revision total hip arthroplasty (THA) in vivo as currently performed at our institution. In this way, the investigators will gain insight into the outcome of the current state of the art of revision arthroplasty surgery. In the past, acetabular and femoral component stability has been measured using radiostereometric analysis (RSA) and when patients having revision total hip operations were compared to patients undergoing primary total hip operations it was possible to determine differences in stability and this was predictive of the intermediate to long-term performance of the acetabular and femoral reconstruction. The investigators propose to use this established, high resolution technique to assess and compare the stability of the revision implants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of Hip, Failure of Primary THA
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
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Revision Total Hip
Arm Type
Experimental
Arm Description
patients recieving a revision total hip replacement will be assessed for implant stability and wear using RSA. Tantalum beads will be placed in the polyethylene and surrounding pelvic and femoral bone.
Intervention Type
Procedure
Intervention Name(s)
Bead placement during revision hip replacement surgery
Intervention Description
Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components
Primary Outcome Measure Information:
Title
Stability of Acetabular and femoral components
Description
RSA films will be taken at the prescribed time intervals to measure component mothion over time.
Time Frame
1, 2, 3, 5 years after surgery
Secondary Outcome Measure Information:
Title
Wear of the polyethlene component
Description
The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.
Time Frame
1, 2, 3, 5 years after surgery
Other Pre-specified Outcome Measures:
Title
Assessment/questionaire HOOS
Description
Hip disability and Osteoarthritis Outcome Score
Time Frame
Pre-op, 1, 2, 3, 5 years after surgery
Title
Assessment/Questionaires Harris Hip Score
Description
Hip specific questionaire
Time Frame
Pre-op, 1, 2, 3, 5 years after surgery
Title
Assessment/Questionaire UCLA Activity Score
Description
Measure of activity level
Time Frame
Pre-op, 1, 2, 3, 5 years after surgery
Title
Assessment/Questionaire EQ-5D
Description
General health and cost effectiveness measure
Time Frame
Pre-op, 1, 2, 3, 5 years after surgery
Title
Assessment/Questionaire Case Mix indicator
Description
Determines comorbidities
Time Frame
Pre-op, 1, 3, 5, 7, 10 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female. 25 to 75 years of age. Subjects requiring revision total hip replacement. 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 complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, or any other major medical complication which could substantially reduce longevity, put them at further risk due to immunocompromisation or increase the risk of infection. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study. A urine HCG will be done in all women of child bearing potential prior to RSA imaging at each follow-up visit. The result will be recorded in the research record.
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

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