MARS MRI in Revision THA With a Ceramic Femoral Head and Titanium Sleeve

Study Overview
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Brief Summary
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Revision total hip replacement using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in individuals doing well after a revision total hip replacement and ceramic bearing surface that utilizes a titanium sleeve.

Detailed Description
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Metal-on-metal total hip arthroplasty (THA) were heralded as a solution for two of the most common problems in hip arthroplasty in the last decade, instability and osteolysis. Unfortunately, their failures have led to diminished enthusiasm for this bearing surface. Adverse local tissue reactions (ATLRs) have been well documented as a means of pain and failure in this population. A recent report revealed that the most commonly used bearing surface in total hip arthroplasty, metal-on-polyethylene, may have up to a 28% incidence of MRI abnormalities in asymptomatic hips. Revision THA using a ceramic head utilizes a titanium sleeve which introduced another articulation into the system that may lead to a local soft tissue reaction. The purpose of this study is to determine the frequency, size and types of MRI documented local tissue reactions in asymptomatic individuals after a revision THA and ceramic bearing surface that utilizes a titanium sleeve. To our knowledge, this has not been studied previously and may provide important baseline features of this diagnostic tool with this particular bearing surface. We hypothesize that there will be fluid collections in a small but clinically significant portion of asymptomatic patients.

Official Title
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Metal Artifact Reduction Sequence MRI in Revision Total Hip Arthroplasty With a Ceramic Femoral Head and Titanium Sleeve

Conditions
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Arthroplasty, Replacement, Hip

Intervention / Treatment
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* Diagnostic Test: MARS MRI
* Diagnostic Test: Titanium Labs
* Diagnostic Test: Cobalt Labs
* Diagnostic Test: Chromium Labs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve Patient whose age ranges from 18-99 Patients who are not experiencing groin pain, thigh pain, or pain with ROM of the hip Patients who are at least 2 years after a revision THA Acetabular implant (cup) was placed in the appropriate position Patients with a Harris Hip Score of >90 Exclusion Criteria: Patients who do not meet the above criteria Patients unable to have an MRI (i.e. pacemaker, metal implants or issues with claustrophobia requiring sedation)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Revision Total Hip Arthroplasty<br>Patients who received a revision total hip surgery utilizing a ceramic femoral head with a titanium sleeve | Diagnostic Test: MARS MRI<br>* metal artifact reduction sequence (MARS) MRI to assess for fluid collections, ATLRs or other abnormalities<br>Diagnostic Test: Titanium Labs<br>* Labs to look at titanium levels in blood<br>Diagnostic Test: Cobalt Labs<br>* Labs to look at cobalt levels in blood<br>Diagnostic Test: Chromium Labs<br>* Labs to look at chromium levels in blood<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MARS MRI abnormalities | Local Tissue Reactions or Fluid collections on the MARS MRI Scan | 2 Years Post Revision Total Hip Replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Titanium Lab Value | Titanium levels in blood | 2 Years Post Revision Total Hip Replacement | 
| Chromium Lab Value | Chromium levels in blood | 2 Years Post Revision Total Hip Replacement | 
| Cobalt Lab Value | Cobalt levels in blood | 2 Years Post Revision Total Hip Replacement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Revision, Titanium Sleeve