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

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ClinicalTrials.gov Identifier: NCT03809520
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Orthopaedic Trauma Association
Information provided by (Responsible Party):
J L Marsh, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Orthopedic Disorder Trauma Ankle Fractures Post-traumatic Osteoarthritis Radiation: pedCAT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: pedCAT
Subjects in this group will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury.
Radiation: pedCAT
Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.




Primary Outcome Measures :
  1. Changes in the ankle joint space width [ Time Frame: 18 months ]
    Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging compared to baseline pedCAT imaging


Secondary Outcome Measures :
  1. Change in ankle pain [ Time Frame: 18 months ]
    Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires

  2. Change in ankle function [ Time Frame: 18 months ]
    Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809520


Contacts
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Contact: Catherine Fruehling, BA 3194678256 catherine-fruehling@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Catherine Fruehling, BA    319-467-8256    catherine-fruehling@uiowa.edu   
Principal Investigator: J L Marsh, MD         
Sponsors and Collaborators
J L Marsh
Orthopaedic Trauma Association
Investigators
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Principal Investigator: J L Marsh, MD University of Iowa

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Responsible Party: J L Marsh, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03809520     History of Changes
Other Study ID Numbers: 201612747
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Ankle Fractures
Musculoskeletal Diseases
Fractures, Bone
Wounds and Injuries