Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-20 @ 6:03 PM
Study NCT ID:
NCT03922256
Status:
COMPLETED
Last Update Posted:
2025-02-26
First Post:
2019-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Observational Clinical Investigation of the Exos Reformable Brace
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092503', 'term': 'Wrist Fractures'}], 'ancestors': [{'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This single-cohort, consecutive series clinical study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2025-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bony union', 'timeFrame': '2-12 weeks', 'description': 'radiographic time to union'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes', 'timeFrame': '2-12 weeks', 'description': 'Visual Analog Scale from 1(no pain) to 100(extreme pain)'}, {'measure': 'Patient Reported Disability Scale- Quick-DASH', 'timeFrame': '2-12 weeks', 'description': '11 questions rating ability of activites - ranging from no difficulty to unable to do'}, {'measure': 'Patient rated Wrist Evaluation', 'timeFrame': '2-12 weeks', 'description': 'Rates pain and function on 1(no pain) to 10 (worst pain)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Distal Radius Fracture']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational single cohort trial quantifying time to radiographic union (primary endpoint) and convenience, satisfaction, pain and resource requirements (secondary) for patients with non-operatively treated distal radius fractures managed with a thermoformable Exos short-arm brace.', 'detailedDescription': "The trial will be a prospective trial of a convenience sample of skeletally mature patients with radiographically-confirmed distal radius fractures that can be managed without ORIF. The study population will be defined as all adult patients (\\>18 years) with stable, non-displaced distal radius fractures. All patients will be independent in activities of daily living. Patients will be screened as candidates for enrollment into the study and if the patient satisfies the inclusion/exclusion criteria, a clinical research coordinator or the study PI/coPI will explain all essential elements of the clinical trial. If the patient agrees to participate, the study coordinator or PI/coPI will obtain informed consent. The patient will still be followed clinically per the PI/coPI's standard of care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion\n\n* Age \\> 18 years;\n* Unilateral fracture of distal radius without misalignment (dorsal angulation \\<10°, axial radial shortening \\<5mm), \\<2mm intraarticular stepoff;\n* Independent in activities of daily living;\n* Capable and willing of signing informed consent.\n\nExclusion\n\n* Children under the age of 18;\n* Fracture of the contralateral arm;\n* Other fractures of the ipsilateral arm;\n* Open fractures;\n* Fractures that require reduction.'}, 'identificationModule': {'nctId': 'NCT03922256', 'acronym': 'EXOS', 'briefTitle': 'Prospective, Observational Clinical Investigation of the Exos Reformable Brace', 'organization': {'class': 'OTHER', 'fullName': 'Foundation for Orthopaedic Research and Education'}, 'officialTitle': 'Prospective, Observational Clinical Investigation of the Exos® Reformable Brace for Conservatively Managed Distal Radius Fractures: An Evaluation of Time to Union, Satisfaction, and Convenience', 'orgStudyIdInfo': {'id': 'FORE EXOS Brace 2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brace Arm', 'description': 'All subjects in this study received the reformable brace', 'interventionNames': ['Other: molded brace']}], 'interventions': [{'name': 'molded brace', 'type': 'OTHER', 'description': 'The moldable brace utilized in the current study will be pre-fabricated and of the short-arm brace variety , which is primarily indicated for non-displaced fractures of the distal radius or distal ulna. The braces are available in multiple sizes for both right and left hands.', 'armGroupLabels': ['Brace Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33736', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Orthopaedic Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Jason Nydick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Florida Orthopaedic Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Foundation for Orthopaedic Research and Education', 'class': 'OTHER'}, 'collaborators': [{'name': 'Encore DJO Global', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}