Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe
Primary Purpose
Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Tomosynthesis of Foot and Ankle
Sponsored by

About this trial
This is an interventional diagnostic trial for Arthritis
Eligibility Criteria
Inclusion Criteria:
- adult age (18 years or older)
- clinical orthopedic surgery follow-up notes available at University of Washington
- ability to complete the Lower Extremity Functional Scale (LEFS) or equivalent questionnaire at the time of the study, a well established survey to test for functional ability in lower extremity
Exclusion Criteria:
- inability to use the simulated weight bearing CT machine due to pain
- prior complete osseous fusion of foot/ankle joints
- prior total ankle arthroplasty
- Pregnancy
Sites / Locations
- University of Washington
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Foot/Ankles imaged with tomosynthesis
Arm Description
Intervention: Digital Tomosynthesis of Foot and Ankle The intervention, digital tomosynthesis of the foot and ankle, will be done on eligible participants. The resulting images will be compared to radiography and weight-bearing CT images from the same participants.
Outcomes
Primary Outcome Measures
Severity of Arthritis (assessed through reading radiologic images and through a pain survey)
Severity of arthritis will be assessed through reading radiologic images and through a pain survey filled out by participants.
Secondary Outcome Measures
Full Information
NCT ID
NCT02432170
First Posted
April 15, 2015
Last Updated
October 24, 2017
Sponsor
University of Washington
1. Study Identification
Unique Protocol Identification Number
NCT02432170
Brief Title
Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe
Official Title
Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to compare digital tomosynthesis with radiography and weight-bearing CT as an imaging technique to assess arthritis in the foot and ankle.
Detailed Description
The overall goal of this study is to improve radiologic evaluation of foot and ankle arthritis. Today's standard of care, radiography, provides limited two-dimensional evaluation of joint alignment, arthritic changes, posttraumatic changes, and congenital deformities due to overlapping bone densities. Evaluation is even more limited in post-surgical patients due to overlapping metallic hardware. Computed tomography (CT), the current problem-solving tool, offers more "level-by-level" three dimensional information, but is fraught with additional cost, additional radiation dose, beam-hardening artifacts from hardware, and the need for additional equipment. Most importantly, patients are not weight-bearing during conventional CT, therefore masking the true extent of malalignment or arthritic joint space narrowing. At the University of Washington, physicians attempt to overcome the last problem by performing simulated weight-bearing CT. The study proposes an alternate solution to this problem using a novel application of an old method, digital tomosynthesis. Specific aims of the study are 1) to compare radiography, tomosynthesis, and simulated-weight bearing CT in their ability to detect foot/ankle malalignment, 2) to compare the abilities of these three modalities to detect arthritis changes such as joint space narrowing, osteophytes, and subchondral cysts, and 3) to compare their abilities to detect bony deformities such as acute fracture, old fracture deformity, or partial fusion (post traumatic or post surgical). Radiographic assessment will be correlated with clinical outcome using clinical notes and functional outcome such as the Lower Extremity Functional Scale (LEFS) questionnaire. Successful results from this initial study will have the potential to change practice paradigm in how to image foot and ankle arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Foot/Ankles imaged with tomosynthesis
Arm Type
Experimental
Arm Description
Intervention: Digital Tomosynthesis of Foot and Ankle
The intervention, digital tomosynthesis of the foot and ankle, will be done on eligible participants. The resulting images will be compared to radiography and weight-bearing CT images from the same participants.
Intervention Type
Device
Intervention Name(s)
Digital Tomosynthesis of Foot and Ankle
Intervention Description
Imaging Technique
Primary Outcome Measure Information:
Title
Severity of Arthritis (assessed through reading radiologic images and through a pain survey)
Description
Severity of arthritis will be assessed through reading radiologic images and through a pain survey filled out by participants.
Time Frame
One day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult age (18 years or older)
clinical orthopedic surgery follow-up notes available at University of Washington
ability to complete the Lower Extremity Functional Scale (LEFS) or equivalent questionnaire at the time of the study, a well established survey to test for functional ability in lower extremity
Exclusion Criteria:
inability to use the simulated weight bearing CT machine due to pain
prior complete osseous fusion of foot/ankle joints
prior total ankle arthroplasty
Pregnancy
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe
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