Stability of Revision Total Hip Arthroplasty Implants Using Radiostereometric Analysis

Study Overview
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Brief Summary
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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.

Official Title
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Analysis of the Stability of Total Hip Arthroplasty Implants Used in Revision Surgery Using Radiostereometric Analysis (RSA)

Conditions
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Osteoarthritis of Hip, Failure of Primary THA

Intervention / Treatment
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* Procedure: Bead placement during revision hip replacement surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Revision Total Hip<br>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<br>* Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of Acetabular and femoral components | RSA films will be taken at the prescribed time intervals to measure component mothion over time. | 1, 2, 3, 5 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wear of the polyethlene component | The movement of the femoral head into the polyethylenen, (wear), will be measured at the prescribed time intervals. | 1, 2, 3, 5 years after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical outcomes, radiographic outcomes, total hip arthroplasty, survivorship