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| Name | Class |
|---|---|
| CurveBeam LLC | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Weightbearing CT (AAFD group) | Experimental | Weightbearing CT scan of affected foot |
|
| Weightbearing CT (control group) | Active Comparator | Weightbearing CT scan of normal foot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Weightbearing CT | Radiation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
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Symptomatic group:
Inclusion Criteria:
1. adult patients (ages 18 -80 years old) diagnosed with Stage 2 AAFD
Exclusion Criteria:
Control group:
Inclusion Criteria:
1. adult patients (ages 18 -80 years old) without foot deformity
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory C Berlet, MD | Orthopedic Foot and Ankle Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Foot and Ankle Center | Westerville | Ohio | 43082 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Weightbearing CT (AAFD Group) | Weightbearing CT scan of affected foot Weightbearing CT |
| FG001 | Weightbearing CT (Control Group) | Weightbearing CT scan of normal foot Weightbearing CT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Weightbearing CT (AAFD Group) | Weightbearing CT scan of affected foot Weightbearing CT |
| BG001 | Weightbearing CT (Control Group) | Weightbearing CT scan of normal foot Weightbearing CT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mm | 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing |
|
4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Weightbearing CT (AAFD Group) | Weightbearing CT scan of affected foot Weightbearing CT |
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Any movement during the scanning process or metal implants caused difficulty with reconstructing the positioning of the bones, therefore those subjects were eliminated from analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Berlet | Orthopedic Foot and Ankle Center | 6148958747 | ofacresearch@orthofootankle.com |
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| ID | Term |
|---|---|
| D005413 | Flatfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Weightbearing CT scan of normal foot
Weightbearing CT
|
|
| 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. | Posted | Mean | Standard Deviation | degrees | 1 CT scan, one reading while touch-down bearing, one reading while full-weight bearing |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Weightbearing CT (Control Group) | Weightbearing CT scan of normal foot Weightbearing CT | 0 | 13 | 0 | 13 | 0 | 13 |
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| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |