Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT03809520
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-18', 'mcpReleaseN': 6, 'releaseDate': '2025-11-04'}], 'estimatedResultsFirstSubmitDate': '2025-11-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D064386', 'term': 'Ankle Fractures'}], 'ancestors': [{'id': 'D050723', 'term': 'Fractures, Bone'}, {'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2018-12-20', 'studyFirstSubmitQcDate': '2019-01-16', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the ankle joint space width', 'timeFrame': '18 months', 'description': 'Tracking longitudinal changes in the 3D joint space width as seen in pedCAT imaging compared to baseline pedCAT imaging'}], 'secondaryOutcomes': [{'measure': 'Change in ankle pain', 'timeFrame': '18 months', 'description': 'Subjective measure of foot and ankle pain gathered by patient reported outcomes questionnaires'}, {'measure': 'Change in ankle function', 'timeFrame': '18 months', 'description': 'Subjective measure of foot and ankle function gathered by patient reported outcomes questionnaires'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Orthopedic Disorder', 'Trauma', 'Ankle Fractures', 'Post-traumatic Osteoarthritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Women who are pregnant or planning on becoming pregnant Individuals younger than 18 and older than 70'}, 'identificationModule': {'nctId': 'NCT03809520', 'briefTitle': 'An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'An Imaging Framework for Clinically Testing New Treatments to Prevent Post-traumatic OA', 'orgStudyIdInfo': {'id': '201612747'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: pedCAT', 'description': 'Subjects in this group will undergo weight-bearing CT (pedCAT) imaging at 6 months, 12 months, and 18 months post-ankle injury.', 'interventionNames': ['Radiation: pedCAT']}], 'interventions': [{'name': 'pedCAT', 'type': 'RADIATION', 'description': 'Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.', 'armGroupLabels': ['Experimental: pedCAT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Catherine Fruehling, BA', 'role': 'CONTACT', 'email': 'catherine-fruehling@uiowa.edu', 'phone': '319-467-8256'}, {'name': 'J L Marsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'centralContacts': [{'name': 'Catherine Fruehling, BA', 'role': 'CONTACT', 'email': 'catherine-fruehling@uiowa.edu', 'phone': '3194678256'}], 'overallOfficials': [{'name': 'J L Marsh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'J L Marsh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Orthopaedic Trauma Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'J L Marsh', 'investigatorAffiliation': 'University of Iowa'}}}}