Suspended

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

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What is being tested

Bead placement during revision hip replacement surgery

Procedure
Who is being recruted

Arthritis+3

+ Joint Diseases

+ Musculoskeletal Diseases

From 25 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2012
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: November 5, 2013
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Study start date: February 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorMassachusetts General Hospital
Last updated: November 5, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 25 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisJoint DiseasesMusculoskeletal DiseasesOsteoarthritisRheumatic DiseasesOsteoarthritis, Hip

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
SuspendedOne Study Center