NCT02432170

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2015

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

April 15, 2015

Last Update Submit

October 24, 2017

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

    One day

Study Arms (1)

Foot/Ankles imaged with tomosynthesis

EXPERIMENTAL

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

Interventions

Digital Tomosynthesis of Foot and AnkleDEVICE

Imaging Technique

Foot/Ankles imaged with tomosynthesis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Radiology

Study Record Dates

First Submitted

April 15, 2015

First Posted

May 4, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

US(1)