Ankle Fractures, Orthopedic Disorder, Post-traumatic Osteoarthritis, Trauma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
RADIATIONpedCAT
Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Sponsors
J L Marsh
Orthopaedic Trauma Association
Arthritis Foundation
University of Washington
University of Utah
University of Kansas Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Individuals 18 to 70 years old Sustained an intra-articular fracture of the tibial plafond Indicated for operative treatment Present for treatment within 4 weeks of injury
Exclusion criteria
* Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up | Final imaging assessed at 18 months or up to 5 years post-injury | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ankle Pain | final follow-up occurred at either 18 months or up to 5 years post-injury | 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. |
| Change in Ankle Function | 18 months or up to 5 years post-injury | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJ L Marsh, MD
University of Iowa
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.3 years STANDARD_DEVIATION 15.2 |
| Region of Enrollment United States | 97 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 97 |
| other Total, other adverse events | 0 / 97 |
| serious Total, serious adverse events | 0 / 97 |
Outcome results
None listed