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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

Tracking Information
First Submitted Date  ICMJE December 20, 2018
First Posted Date  ICMJE January 18, 2019
Last Update Posted Date January 24, 2019
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2019)
  • Change in ankle pain [ Time Frame: 18 months ]
    Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires
  • Change in ankle function [ Time Frame: 18 months ]
    Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
Official Title  ICMJE An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Orthopedic Disorder
  • Trauma
  • Ankle Fractures
  • Post-traumatic Osteoarthritis
Intervention  ICMJE Radiation: pedCAT
Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
Study Arms  ICMJE 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.
Intervention: Radiation: pedCAT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 16, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Catherine Fruehling, BA 3194678256 catherine-fruehling@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03809520
Other Study ID Numbers  ICMJE 201612747
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party J L Marsh, University of Iowa
Study Sponsor  ICMJE J L Marsh
Collaborators  ICMJE Orthopaedic Trauma Association
Investigators  ICMJE
Principal Investigator: J L Marsh, MD University of Iowa
PRS Account University of Iowa
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP