Back to resultsWeightbearing Assessment of Tarsal Instability (WBCT)
Primary Purpose
Adult-acquired Flatfoot Disorder (AAFD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weightbearing CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Adult-acquired Flatfoot Disorder (AAFD) focused on measuring Adult-acquired flatfoot disorder (AAFD), flexible flatfoot, computed tomography (CT)
Eligibility Criteria
Symptomatic group:
Inclusion Criteria:
1. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD
Exclusion Criteria:
- previous surgery
- infection
- tumor in the affected foot
- pregnancy
Control group:
Inclusion Criteria:
1. adult patients (ages 18 -80 years old) without foot deformity
Exclusion Criteria:
- history of previous foot and ankle surgery
- foot deformity
- known foot and ankle pathology
- pregnancy
Sites / Locations
- Orthopedic Foot and Ankle Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Weightbearing CT (AAFD group)
Weightbearing CT (control group)
Arm Description
Weightbearing CT scan of affected foot
Weightbearing CT scan of normal foot
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01868789
First Posted
May 24, 2013
Last Updated
January 31, 2018
Sponsor
Orthopedic Foot and Ankle Center, Ohio
Collaborators
CurveBeam LLC
1. Study Identification
Unique Protocol Identification Number
NCT01868789
Brief Title
Weightbearing Assessment of Tarsal Instability
Acronym
WBCT
Official Title
In-Vivo Physiologic Weight-Bearing Assessment of Tarsal Instability: Three-Dimensional Cone-Beam Computed Tomography Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Orthopedic Foot and Ankle Center, Ohio
Collaborators
CurveBeam LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult-acquired Flatfoot Disorder (AAFD)
Keywords
Adult-acquired flatfoot disorder (AAFD), flexible flatfoot, computed tomography (CT)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weightbearing CT (AAFD group)
Arm Type
Experimental
Arm Description
Weightbearing CT scan of affected foot
Arm Title
Weightbearing CT (control group)
Arm Type
Active Comparator
Arm Description
Weightbearing CT scan of normal foot
Intervention Type
Radiation
Intervention Name(s)
Weightbearing CT
Primary Outcome Measure Information:
Title
Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular
Description
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.
Time Frame
1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
Title
Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing
Description
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.
Time Frame
1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Symptomatic group:
Inclusion Criteria:
1. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD
Exclusion Criteria:
previous surgery
infection
tumor in the affected foot
pregnancy
Control group:
Inclusion Criteria:
1. adult patients (ages 18 -80 years old) without foot deformity
Exclusion Criteria:
history of previous foot and ankle surgery
foot deformity
known foot and ankle pathology
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory C Berlet, MD
Organizational Affiliation
Orthopedic Foot and Ankle Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopedic Foot and Ankle Center
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43082
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weightbearing Assessment of Tarsal Instability
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