Adult-acquired Flatfoot Disorder (AAFD)
Conditions
Keywords
Adult-acquired flatfoot disorder (AAFD), flexible flatfoot, computed tomography (CT)
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.
Interventions
RADIATIONWeightbearing CT
Sponsors
CurveBeam LLC
Orthopedic Foot and Ankle Center, Ohio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Weightbearing CT (AAFD Group) Weightbearing CT scan of affected foot
Weightbearing CT | 7 |
| Weightbearing CT (Control Group) Weightbearing CT scan of normal foot
Weightbearing CT | 12 |
| Total | 19 |
Baseline characteristics
| Characteristic | Weightbearing CT (Control Group) | Total | Weightbearing CT (AAFD Group) |
|---|---|---|---|
| Age, Continuous | 52.2 years | 49.0 years | 43.6 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 12 participants | 19 participants | 7 participants |
| Sex: Female, Male Female | 10 Participants | 13 Participants | 3 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 13 |
| other Total, other adverse events | 0 / 9 | 0 / 13 |
| serious Total, serious adverse events | 0 / 9 | 0 / 13 |
Outcome results
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.
Time frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Weightbearing CT (AAFD Group) | Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular | Translation of the Navicular | 3.56 mm | Standard Deviation 2.15 |
| Weightbearing CT (AAFD Group) | Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular | axis of navicular rotation: x component | -0.1666 mm | Standard Deviation 0.338 |
| Weightbearing CT (AAFD Group) | Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular | axis of navicular rotation: y component | 0.867 mm | Standard Deviation 0.159 |
| Weightbearing CT (AAFD Group) | Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular | axis of navicular rotation: z component | -0.083 mm | Standard Deviation 0.331 |
| Weightbearing CT (Control Group) | Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular | axis of navicular rotation: z component | 0.084 mm | Standard Deviation 0.171 |
| Weightbearing CT (Control Group) | Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular | Translation of the Navicular | 4.36 mm | Standard Deviation 2.16 |
| Weightbearing CT (Control Group) | Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular | axis of navicular rotation: y component | 0.950 mm | Standard Deviation 0.045 |
| Weightbearing CT (Control Group) | Change in Joint Motion Between Touch-down Bearing Navicular and Full-weight Bearing Navicular | axis of navicular rotation: x component | -0.170 mm | Standard Deviation 0.188 |
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.
Time frame: 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weightbearing CT (AAFD Group) | Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing | 4.11 degrees | Standard Deviation 2.19 |
| Weightbearing CT (Control Group) | Change in Navicular Rotation Between Touch-down Bearing and Full-weight Bearing | 5.99 degrees | Standard Deviation 3.26 |