Pilot Study Comparing Diagnostic Imaging Versus Tomosynthesis in Detection of Hip, Wrist or Tibia Injury

Study Overview
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Brief Summary
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To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.

Detailed Description
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Subjects presenting with a wrist injury, tibial fracture, or hip injury that require protocol defined standard imaging will have an X-Ray, CT Scan (or MRI per site preference) and TOMO completed. Images will be assessed to determine if TOMO is appropriate to supplement or replace the need for the other standard images.

Official Title
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Pilot Study Comparing Diagnostic Imagining Versus FujiFilm's Digital Radiographic AcSellerate CsI System With Tomosynthesis

Conditions
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Wrist Injury, Tibial Fracture, Hip Injury

Intervention / Treatment
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* Device: Standard X-Ray + CT
* Device: Standard X-Ray + MRI
* Device: TOMO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician request to have diagnostic imaging for condition areas Exclusion Criteria: Under 18 Pregnancy Insufficient Anatomical Coverage or Potential Image Problems

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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard X-Ray + CT<br>Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis. | Device: Standard X-Ray + CT<br>* Standard of Care X-Ray Imaging + CT<br>Device: TOMO<br>* Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis<br>|
| Active Comparator: Standard X-Ray + MRI<br>Standard X-Ray + MRI arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis. | Device: Standard X-Ray + MRI<br>* Standard of Care X-Ray Imaging + MRI<br>Device: TOMO<br>* Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis<br>|
| Experimental: Tomo<br>Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis | Device: Standard X-Ray + CT<br>* Standard of Care X-Ray Imaging + CT<br>Device: Standard X-Ray + MRI<br>* Standard of Care X-Ray Imaging + MRI<br>Device: TOMO<br>* Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants for Whom Tibia Injury Was Detected | Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) [or designee] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems. | Baseline Imaging Collection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TOMOSYNTHESIS