Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01668160
Recruitment Status : Withdrawn
First Posted : August 17, 2012
Last Update Posted : November 5, 2013
Information provided by (Responsible Party):
Charles R. Bragdon, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of Hip Failure of Primary THA Procedure: Bead placement during revision hip replacement surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)
Study Start Date : February 2012
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Stability of Acetabular and femoral components [ Time Frame: 1, 2, 3, 5 years after surgery ]
    RSA films will be taken at the prescribed time intervals to measure component mothion over time.

Secondary Outcome Measures :
  1. Wear of the polyethlene component [ Time Frame: 1, 2, 3, 5 years after surgery ]
    The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals.

Other Outcome Measures:
  1. Assessment/questionaire HOOS [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ]
    Hip disability and Osteoarthritis Outcome Score

  2. Assessment/Questionaires Harris Hip Score [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ]
    Hip specific questionaire

  3. Assessment/Questionaire UCLA Activity Score [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ]
    Measure of activity level

  4. Assessment/Questionaire EQ-5D [ Time Frame: Pre-op, 1, 2, 3, 5 years after surgery ]
    General health and cost effectiveness measure

  5. Assessment/Questionaire Case Mix indicator [ Time Frame: Pre-op, 1, 3, 5, 7, 10 years after surgery ]
    Determines comorbidities

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01668160

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital

Responsible Party: Charles R. Bragdon, Reseach scientist, Massachusetts General Hospital Identifier: NCT01668160     History of Changes
Other Study ID Numbers: 2012P000925
216494 ( Other Grant/Funding Number: MGH Orhtopaedic Department Funds 216494 )
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: November 5, 2013
Last Verified: November 2013

Keywords provided by Charles R. Bragdon, Massachusetts General Hospital:
clinical outcomes
radiographic outcomes
total hip arthroplasty

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