An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA

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.

Study Overview

• Status: Completed
• Conditions: Post-traumatic Osteoarthritis; Trauma; Orthopedic Disorder; Ankle Fractures
• Intervention / Treatment: Radiation: pedCAT

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 Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Radiation: pedCAT; Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: J L Marsh
• Collaborators: University of Washington; University of Kansas Medical Center; University of Utah; Orthopaedic Trauma Association; Arthritis Foundation
• Investigators: Principal Investigator: J L Marsh, MD, University of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Fractures, Bone; Ankle Injuries; Wounds and Injuries; Ankle Fractures; Musculoskeletal Diseases
• Other Study ID Numbers: 201612747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No