Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2025-12-26 @ 2:33 AM
Study NCT ID:
NCT04402502
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2020-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dynamic 4DCT to Examine Wrist Carpal Mechanics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Healthy Population'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2020-05-20', 'studyFirstSubmitQcDate': '2020-05-22', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hand Joint Spacing', 'timeFrame': '3 years', 'description': 'To measure joint spacing of the hand in a 3D ultrasound image'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D Ultrasound Monitoring'], 'conditions': ['Osteoarthritis']}, 'descriptionModule': {'briefSummary': "Osteoarthritis can develop after an injury like a broken bone. Problems with how the bones line up can lead to abnormal loading which will destroy the cartilage that covers and protects the bones. Once this happens, patients experience substantial pain and disability. Researchers and doctors use planar x-rays to evaluate joints; but these are not always precise and are limited to two dimensions. Three-dimensional (3D) computed tomography (CT) can be used to look at the joints of the wrist in three dimensions, but is limited to static frames. Symptoms arising from joint instability often occur when the wrist is moving and when it is performing a functional task (opening a jar). Four dimensional computed tomography (4DCT) can detect dynamics changes in the small structures of the wrist with high temporal and spatial resolution. This novel imaging techniques provides a movie of bones in the wrist, in 3D, while in the scanner. In this proposal, the investigator's will use 4DCT and look at how joint alignment of the distal radius effects the joints in the wrist, and investigate how it relates to patient's function, description of pain and the presence of Osteoarthritis 10 years following fracture. This imaging will drive safer clinical research and practice and will develop tools that predict the risk of developing arthritis that will help doctors determine when surgery is necessary to prevent arthritis of the hand and wrist, and pain and disability.", 'detailedDescription': 'A series of 60 participants (30 male: 30 female) with current distal radius fractures will be recruited. Clinical eligibility will include a unilateral DRF treated with closed reduction and casting. These measures will be assessed at baseline (\\<6 weeks following injury), 3- 6 months and 12 months following fracture. A second series of 80 participants (40 male: 40 female) who suffered a DRF ≥10 years previously will be recruited and tested. Exclusion criteria for these two cohorts will include presence of neurological disorders, rheumatoid arthritis or co-morbid health conditions that preclude completion of study measures. Twenty additional healthy participants will be recruited.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fluent in English, capacity to provide consent,\n* over the age of 18 years old, with no previous injury to either hand or wrist\n\nExclusion Criteria:\n\n* pregnancy and presence of neurological disorders, rheumatoid arthritis or comorbid health conditions that preclude completion of study measures'}, 'identificationModule': {'nctId': 'NCT04402502', 'briefTitle': 'Dynamic 4DCT to Examine Wrist Carpal Mechanics', 'organization': {'class': 'OTHER', 'fullName': 'Western University, Canada'}, 'officialTitle': 'Dynamic 4DCT to Examine the Effect of Mal-united Distal Radius Fractures on Carpal Contact Mechanics', 'orgStudyIdInfo': {'id': '5147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Population', 'description': 'Healthy Individuals with no presence of neurological disorders, rheumatoid arthritis or comorbid health conditions, and are not pregnant.', 'interventionNames': ['Device: Ultrasound Imaging']}], 'interventions': [{'name': 'Ultrasound Imaging', 'type': 'DEVICE', 'description': "The participant will go to the Rheumatology clinic (St. Joseph's Hospital) and have 3D hand ultrasound performed on their hands.", 'armGroupLabels': ['Healthy Population']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Hospital", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western University, Canada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}