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Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

This study is currently recruiting participants.
Verified August 2012 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Charles R. Bragdon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01668160
First received: August 10, 2012
Last updated: August 28, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis of Hip
Failure of Primary THA
 Procedure: Bead placement during revision hip replacement surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Stability of Acetabular and femoral components [ Time Frame: 1, 2, 3, 5 years after surgery ] [ Designated as safety issue: No ]
    RSA films will be taken at the prescribed time intervals to measure component mothion over time.


Secondary Outcome Measures:
  • Wear of the polyethlene component [ Time Frame: 1, 2, 3, 5 years after surgery ] [ Designated as safety issue: No ]
    The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.


Other Outcome Measures:
  • Assessment/questionaire HOOS [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ] [ Designated as safety issue: No ]
    Hip disability and Osteoarthritis Outcome Score

  • Assessment/Questionaires Harris Hip Score [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ] [ Designated as safety issue: No ]
    Hip specific questionaire

  • Assessment/Questionaire UCLA Activity Score [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ] [ Designated as safety issue: No ]
    Measure of activity level

  • Assessment/Questionaire EQ-5D [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ] [ Designated as safety issue: No ]
    General health and cost effectiveness measure

  • Assessment/Questionaire Case Mix indicator [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ] [ Designated as safety issue: No ]
    Determines comorbidities


Estimated Enrollment: 100
Study Start Date: February 2012
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Revision Total Hip
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.
 Procedure: Bead placement during revision hip replacement surgery
Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668160

Contacts
Contact: Charles Bragdon, PhD 617-967-0274 cbragdon@partners.org
Contact: Janet Dorrwachter, NP 617-726-2939 jdorrwachter@mghihp.edu

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Charles Bragdon, PhD     617-724-7544     cbragdon@partners.org    
Contact: Janet Dorrwachter, NP     781-223-4475        
Principal Investigator: Charles Bragdon, PhD            
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Charles R. Bragdon, Reseach scientist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01668160     History of Changes
Other Study ID Numbers: 2012P000925, 216494
Study First Received: August 10, 2012
Last Updated: August 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
clinical outcomes
radiographic outcomes
total hip arthroplasty
survivorship

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 19, 2013