Weightbearing Assessment of Tarsal Instability

Not Applicable

Completed

• Conditions: Adult-acquired Flatfoot Disorder (AAFD)
• Interventions: Radiation: Weightbearing CT

• Registration Number: NCT01868789
• Lead Sponsor: Orthopedic Foot and Ankle Center, Ohio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-24
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-06-05
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Disposition First Submitted: 2015-04-22
• Disposition First Submitted QC: 2015-05-08
• Disposition First Posted: 2015-05-28
• Results First Submitted: 2017-11-03
• Results First Submitted QC: 2017-12-14
• Status Verified: 2018-01
• Results First Posted: 2018-01-18
• Last Update Submitted: 2018-01-31
• Last Update Posted: 2018-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weightbearing CT (AAFD group)	Weightbearing CT	Weightbearing CT scan of affected foot
Weightbearing CT (control group)	Weightbearing CT	Weightbearing CT scan of normal foot

Primary Outcome Measures

Name	Time	Method
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular	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.
Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing	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.

Trial Locations

Locations (1)

Orthopedic Foot and Ankle Center; 🇺🇸 Westerville, Ohio, United States