Weightbearing Assessment of Tarsal Instability (WBCT)

January 31, 2018 updated by: Orthopedic Foot and Ankle Center, Ohio

In-Vivo Physiologic Weight-Bearing Assessment of Tarsal Instability: Three-Dimensional Cone-Beam Computed Tomography Analysis

The purpose of this study is to compare the average joint motion and joint axis orientation of the hindfoot bones between patients diagnosed with adult-acquired flatfoot disorder (AAFD) and a control group of patients without foot deformity, using weight-bearing CT technology.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Westerville, Ohio, United States, 43082
        • Orthopedic Foot and Ankle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Symptomatic group:

Inclusion Criteria:

1. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD

Exclusion Criteria:

  1. previous surgery
  2. infection
  3. tumor in the affected foot
  4. pregnancy

Control group:

Inclusion Criteria:

1. adult patients (ages 18 -80 years old) without foot deformity

Exclusion Criteria:

  1. history of previous foot and ankle surgery
  2. foot deformity
  3. known foot and ankle pathology
  4. pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Weightbearing CT (AAFD group)
Weightbearing CT scan of affected foot
Radiation: Weightbearing CT
Active Comparator: Weightbearing CT (control group)
Weightbearing CT scan of normal foot
Radiation: Weightbearing CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular
Time Frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Relative motion, which is the position of the full weightbearing (FWB, greater that 75-100% body weight) navicular in comparison to the touch down weightbearing (TDWB, 25-50% body weight) navicular position, will be determined by comparing the joint orientation across these two points on one CT scan. The difference between the two positions is reported below.
1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing
Time Frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Relative motion across joint segments will be determined by comparing the joint orientation across two time points: touch-down bearing (TDWB, 25-50% body weight) and full-weight bearing (FWB, greater that 75-100% body weight) as measured on CT.
1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orthopedic Foot and Ankle Center, Ohio

Collaborators

CurveBeam LLC

Investigators

  • Principal Investigator: Gregory C Berlet, MD, Orthopedic Foot and Ankle Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

May 30, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OH1-12-00397

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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