Prosthesis Loosening Imaging With Dual Energy and Tomosynthesis

Study Overview
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Brief Summary
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The purpose is to determine diagnostic performances of flat panel dual energy arthrography and arthro-tomosynthesis in identification of loosening of painful hip prosthesis, taking as reference the results of surgery performed 6 months after arthrography. Secondary purposes are: To describe the level of concordance of each technique with the indication for surgery To study inter-technique concordance with kappa coefficient To study the relationship between density differential between 2 acquisitions and grey level on subtraction, i.e. subtraction quality according to metal

Detailed Description
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Hip arthroplasty has become one of the most performed orthopedic procedures. Actual average lifetime of total hip prosthesis is approximately 15 years. Some complications are inevitable. Total hip prosthesis imaging, performed to search for a complication or wear, is difficult and depends on many techniques. Subtracted arthrography is a good technique but its access is limited because it needs an angiography room. In this study patients undergo standard arthrography, dual energy arthrography, arthro-tomosynthesis and arthro-tomography.

Official Title
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Study of Diagnostic Performances of Dual Energy Imaging With Flat Detectors and Tomosynthesis in Identification of Loosening of Painful Hip Prosthesis

Conditions
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Hip Prosthesis Imaging

Intervention / Treatment
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* Procedure: Standard arthrography
* Procedure: Dual energy arthrography
* Procedure: Arthro-tomosynthesis
* Procedure: Arthro-tomography
* Procedure: Surgery on painful prosthesis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients sent for arthro-tomography of painful prosthesis, without contraindications to arthrography or injection of contrast agent Aware and cooperative Signed informed consent Affiliation to social security Exclusion Criteria: Any contraindication to arthrography or injection of contrast agent Pregnant or possibly pregnant women Patient under guardianship Refusal or impossibility of informed consent

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with painful prosthesis<br> | Procedure: Standard arthrography<br> <br> Procedure: Dual energy arthrography<br> <br> Procedure: Arthro-tomosynthesis<br> <br> Procedure: Arthro-tomography<br> <br> Procedure: Surgery on painful prosthesis<br>* Possibly performed during 6 months from arthrography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of prosthesis loosening detected with 3 radiographic techniques (dual-energy arthrography, arthro-tomosynthesis and single-energy tomography) and surgery | Gold standard is presence or absence of prosthesis loosening revealed with surgery performed after 6 months from arthrography. Data of patients undergone surgery and not are collected and analyzed. Any clinical or imagery sign of loosening in non-operated patient, will be classified as loosening. A surgery decision for suspicion of loosening will be considered loosening. | from day 0 up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between density differential between 2 acquisitions and grey level on subtraction |  | day 0 |