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Completed

NCT Number: NCT03809520

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.

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Key information

Conditions

Orthopedic Disorder Ankle Fractures Ankle Injuries Fractures, Bone Leg Injuries Musculoskeletal Diseases Post-traumatic Osteoarthritis Trauma Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pedCAT

Radiation

Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Ankle Pain

    Time frame: 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.

  2. Change in Ankle Function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

J L Marsh

Other

Collaborators

  • Arthritis Foundation
  • Orthopaedic Trauma Association
  • University of Kansas Medical Center
  • University of Utah
  • University of Washington

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2019
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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