Expired Study
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Seattle, Washington 98105


Purpose:

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.


Study summary:

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.


Criteria:

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


Study is Available At:


Original ID:

48992


NCT ID:

NCT02432170


Secondary ID:


Study Acronym:


Brief Title:

Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe


Official Title:

Weight-Bearing Tomosynthesis In Evaluation of Foot/AnkIe


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Washington


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

47


Enrollment Type:

Actual


Study Dates

Start Date:April 2015
Completion Date:April 2017
Completion Type:Actual
Primary Completion Date:April 2017
Primary Completion Type:Actual
Verification Date:October 2017
Last Changed Date:October 24, 2017
First Received Date:April 15, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Severity of Arthritis (assessed through reading radiologic images and through a pain survey)
Time Frame:One day
Safety Issues:False
Description:Severity of arthritis will be assessed through reading radiologic images and through a pain survey filled out by participants.

Study Interventions

Intervention Type:Device
Name:Digital Tomosynthesis of Foot and Ankle
Description:Imaging Technique
Arm Name:Foot/Ankles imaged with tomosynthesis

Study Arms

Study Arm Type:Experimental
Arm Name:Foot/Ankles imaged with tomosynthesis
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Washington

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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