Orthopedic DisorderNCT03809520
An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
A study testing pedCAT in people with Orthopedic Disorder and Trauma, run by J L Marsh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Orthopedic Disorder, Trauma, Ankle Fractures
- What is being tested?
- pedCAT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2017to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Being tested
- pedCAT
- Medical subject headings
- Musculoskeletal Diseases, Wounds and Injuries, Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pedCATRadiation
Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: pedCAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Final imaging assessed at 18 months or up to 5 years post-injury
Secondary outcomes (2)
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.
Measured: 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
Measured: 18 months or up to 5 years post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Feb 2017
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- J L Marsh
- Sponsor type
- University, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Arthritis Foundation, University of Washington, University of Utah, University of Kansas Medical Center
- Responsible party
- Sponsor-investigator, J L Marsh, University of Iowa
- Investigators
- J L Marsh, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809520
- Sponsor's protocol ID
- 201612747
- Status last verified
- Sep 2025
- First submitted
- 20 Dec 2018
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
- ClinicalTrials.gov ID
- NCT03809520
- Acronym / sponsor ID
- 201612747
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- J L MarshUniversity, hospital or other
- Collaborators
- Orthopaedic Trauma Association, Arthritis Foundation, University of Washington, University of Utah, University of Kansas Medical Center
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 24 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: pedCAT | Experimental | Radiation: pedCATSubjects 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pedCATWeight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture. | Radiation | Experimental: pedCAT |
Primary outcome
Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up
Time frame: 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.
2 secondary outcomes
Change in Ankle Pain
Time frame: final follow-up occurred at either 18 months or up to 5 years post-injury
Change in Ankle Function
Time frame: 18 months or up to 5 years post-injury
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J L Marsh, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pedCAT in people with Orthopedic Disorder and Trauma, run by J L Marsh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Ankle Joint Space Width Between Baseline and Final Follow-up (time frame: Final imaging assessed at 18 months or up to 5 years post-injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.