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| Name | Class |
|---|---|
| Orthopaedic Trauma Association | OTHER |
| Arthritis Foundation | OTHER |
| University of Washington | OTHER |
| University of Utah |
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The immediate goal of the proposed research is to test the value of a new low-cost, low-dose standing CT system for efficient early detection of both joint degeneration and elevated contact stress. The standing CT scanner holds promise for detecting arthritic changes earlier than other imaging modalities because of the combination of its 3D nature and ability to image joints in a weight-bearing pose. A secondary goal of the proposed research is to enable predictive models for osteoarthritis risk based on measures of post treatment contact stress, both to inform treatment and so that new interventions can be tested in a manner incorporating risk stratification.
Individuals who present with an intra-articular of the tibial plafond will be consented to participate in this study. We will obtain pedCAT scans at 6, 12, and 18 months post-injury, as well as several questionnaires that will be administered during the clinical visits. We will also review the subjects' electronic medical record for data related to the injury, including the timing and mechanism of injury, time from injury to surgery, length of hospital stay, any complications and/or subsequent ankle surgeries, as well as any clinic notes, imaging, and/or outcomes scores related to the calcaneus fracture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: pedCAT | Experimental | Subjects will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury. Additional funding was secured and follow-up for subjects initially enrolled under OTA funding was extended to include yearly follow-up through 5 years post ankle injury |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pedCAT | Radiation | Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up | Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging at the final follow-up visit using contralateral, uninjured side as control. Final follow-up occurred at 18 month follow-up or at 5 years follow-up. | Final imaging assessed at 18 months or up to 5 years post-injury |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ankle Pain | Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaire at final follow-up visit. The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference instrument was utilized. Scores are reported as T-scores from a representative group of US adults. The mean for the US population is 50 and the standard deviation is 10. HIgher PROMIS T-scores indicate a greater amount of the health domain being measured. In this case, a higher T-score of PROMIS Pain Interference indicates greater pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J L Marsh, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: pedCAT | Subjects will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury. Additional funding was secured and follow-up for subjects initially enrolled under OTA funding was extended to include yearly follow-up through 5 years post ankle injury pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental: pedCAT | Subjects will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury. Additional funding was secured and follow-up for subjects initially enrolled under OTA funding was extended to include yearly follow-up through 5 years post ankle injury pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture. |
| 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 | Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up | Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging at the final follow-up visit using contralateral, uninjured side as control. Final follow-up occurred at 18 month follow-up or at 5 years follow-up. | joint space width, minimum value | Posted | Mean | Standard Deviation | mm | Final imaging assessed at 18 months or up to 5 years post-injury |
|
duration of study (participants could be followed up to 5 months post-injury)
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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 | Experimental: pedCAT | Subjects will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury. Additional funding was secured and follow-up for subjects initially enrolled under OTA funding was extended to include yearly follow-up through 5 years post ankle injury pedCAT: Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J. Lawrence Marsh | University of Iowa, Department of Orthopedics & Rehabilitation | 3193849046 | natalie-glass@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2025 | Oct 24, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
| D064386 | Ankle Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D016512 | Ankle Injuries |
| D007869 | Leg Injuries |
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| OTHER |
| University of Kansas Medical Center | OTHER |
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| final follow-up occurred at either 18 months or up to 5 years post-injury |
| Change in Ankle Function | Subjective measure of foot and ankle function measured using the Foot and Ankle Ability Measure (FAAM) questionnaire. Scores range from 0-100%. higher is better. Scores were initially collected at 6 month visit Final scores collected at 18 month visit or up to 5 years post-injury | 18 months or up to 5 years post-injury |
| years |
|
| Sex: Female, Male | data not collected on all subjects | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Secondary | Change in Ankle Pain | Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaire at final follow-up visit. The Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference instrument was utilized. Scores are reported as T-scores from a representative group of US adults. The mean for the US population is 50 and the standard deviation is 10. HIgher PROMIS T-scores indicate a greater amount of the health domain being measured. In this case, a higher T-score of PROMIS Pain Interference indicates greater pain. | Posted | Mean | Standard Deviation | T-score | final follow-up occurred at either 18 months or up to 5 years post-injury |
|
|
|
| Secondary | Change in Ankle Function | Subjective measure of foot and ankle function measured using the Foot and Ankle Ability Measure (FAAM) questionnaire. Scores range from 0-100%. higher is better. Scores were initially collected at 6 month visit Final scores collected at 18 month visit or up to 5 years post-injury | Posted | Mean | Standard Deviation | score on a scale | 18 months or up to 5 years post-injury |
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| 0 |
| 97 |
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| 97 |
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| 97 |
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