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Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02432170
Recruitment Status : Completed
First Posted : May 4, 2015
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):
Alice Ha, University of Washington

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.

Condition or disease Intervention/treatment Phase
Arthritis Device: Digital Tomosynthesis of Foot and Ankle Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe
Study Start Date : April 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Foot/Ankles imaged with tomosynthesis

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.

Device: Digital Tomosynthesis of Foot and Ankle
Imaging Technique

Primary Outcome Measures :
  1. Severity of Arthritis (assessed through reading radiologic images and through a pain survey) [ Time Frame: One day ]
    Severity of arthritis will be assessed through reading radiologic images and through a pain survey filled out by participants.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. adult age (18 years or older)
  2. clinical orthopedic surgery follow-up notes available at University of Washington
  3. 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:

  1. inability to use the simulated weight bearing CT machine due to pain
  2. prior complete osseous fusion of foot/ankle joints
  3. prior total ankle arthroplasty
  4. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02432170

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United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
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Responsible Party: Alice Ha, Associate Professor, Radiology, University of Washington Identifier: NCT02432170    
Other Study ID Numbers: 48992
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases