Condition or disease | Intervention/treatment | Phase |
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Orthopedic Disorder Trauma Ankle Fractures Post-traumatic Osteoarthritis | Radiation: pedCAT | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | N/A |
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, 2022 |
Estimated Study Completion Date : | December 31, 2023 |
Arm | Intervention/treatment |
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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.
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Radiation: pedCAT
Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Catherine Fruehling, BA | 3194678256 | catherine-fruehling@uiowa.edu |
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 |
Principal Investigator: | J L Marsh, MD | University of Iowa |
Tracking Information | |||||||
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First Submitted Date ICMJE | December 20, 2018 | ||||||
First Posted Date ICMJE | January 18, 2019 | ||||||
Last Update Posted Date | October 22, 2020 | ||||||
Actual Study Start Date ICMJE | January 1, 2017 | ||||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE | Radiation: pedCAT
Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
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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
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Recruiting | ||||||
Estimated Enrollment ICMJE |
20 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | December 31, 2023 | ||||||
Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | J L Marsh, University of Iowa | ||||||
Study Sponsor ICMJE | J L Marsh | ||||||
Collaborators ICMJE | Orthopaedic Trauma Association | ||||||
Investigators ICMJE |
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PRS Account | University of Iowa | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |