Weightbearing Assessment of Tarsal Instability

Adult-acquired Flatfoot Disorder (AAFD) Clinical Trial

— WBCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01868789
• Other study ID #: OH1-12-00397
• Status: Completed
• Phase: N/A
• First received: May 24, 2013
• Last updated: January 31, 2018
• Start date: May 2013
• Est. completion date: November 2013

Study information

• Verified date: January 2018
• Source: Orthopedic Foot and Ankle Center, Ohio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult-acquired Flatfoot Disorder (AAFD)
• Flatfoot

Intervention

Radiation:
• Weightbearing CT

Locations

Country	Name	City	State
United States	Orthopedic Foot and Ankle Center	Westerville	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Orthopedic Foot and Ankle Center, Ohio	CurveBeam LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular	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
Primary	Change in Navicular Rotation Between Touch-down Bearing and 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