Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 7:48 AM
Study NCT ID:
NCT00587795
Status:
TERMINATED
Last Update Posted:
2017-08-02
First Post:
2007-12-21
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011885', 'term': 'Radius Fractures'}], 'ancestors': [{'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002370', 'term': 'Casts, Surgical'}], 'ancestors': [{'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D009984', 'term': 'Orthopedic Fixation Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D053831', 'term': 'Surgical Fixation Devices'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Dennison.David@mayo.edu', 'phone': '507-284-7405', 'title': 'Dr. David Dennison', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to inability to enroll subjects, and concern about subject compliance in the use of the Stabilair wrist brace. The one subject enrolled disliked the brace and quickly withdrew from the study.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'StabilAir Wrist Brace', 'description': 'One study group will consist of patients treated with the StabilAir Wrist Brace.\n\nStabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.\n\nPlacement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Distal Radius Fracture at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'StabilAir Wrist Brace', 'description': 'One study group will consist of patients treated with the StabilAir Wrist Brace.\n\nStabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.\n\nPlacement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.'}], 'timeFrame': 'baseline, 8 weeks', 'description': 'The investigators planned to make radiographic assessments using the Stewart Score. The Stewart Score can range from 1 to 12, with a higher score indicating poor function: excellent (0), good (1-3), fair (4-6) and poor (7-12).', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'StabilAir Wrist Brace', 'description': 'One study group will consist of patients treated with the StabilAir Wrist Brace.\n\nStabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.\n\nPlacement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'One subject was recruited from the Mayo Clinic in Rochester, Minnesota in 2007.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'StabilAir Wrist Brace', 'description': 'One study group will consist of patients treated with the StabilAir Wrist Brace.\n\nStabilAir Wrist Brace: Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.\n\nPlacement of sugar tong splint or plaster cast: Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Inability to enroll subjects', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2007-12-21', 'resultsFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-25', 'studyFirstPostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Distal Radius Fracture at 8 Weeks', 'timeFrame': 'baseline, 8 weeks', 'description': 'The investigators planned to make radiographic assessments using the Stewart Score. The Stewart Score can range from 1 to 12, with a higher score indicating poor function: excellent (0), good (1-3), fair (4-6) and poor (7-12).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Radius Fractures']}, 'descriptionModule': {'briefSummary': 'Objectives:\n\n\\- To obtain clinical evidence for the safety and efficacy in using the StabilAir Wrist Fracture Brace for the following cases:\n\n1. Acute (emergency department) treatment of non-displaced, stable extra- articular distal radius fractures;\n2. To obtain comparative data between traditional therapies (sugar tong, plaster backslab, long arm or short arm cast) and the use of the StabilAir brace for each patient qualified by specific criteria.\n\nHypothesis:\n\n1\\) For stable, non-displaced fractures, the StabilAir Brace is as effective as a sugar tong splint in the acute setting. 2) In cases where full forearm immobilization is initially preferred, the StabilAir is effective as a follow-up to sugar tong splitting once the need for full immobilization has passed.', 'detailedDescription': "Data Collection and Study Design:\n\nThis will be a single center, prospective, randomized controlled trial. The investigators planned to collect data from 80 patients with undisplaced distal radius fractures. Half were to be treated with the plastic back slab or sugar tong splint (if there were an ulnar styloid fracture) and half were to be treated with the StabilAir splint. The initial treatment, which was to occur upon the patient's arrival at the emergency room and prior to study randomization, required full forearm and wrist immobilization in the acute phase treated with sugar tong splinting. At the patient's follow-up visit, which was to happen ≤10 days post injury and initial evaluation, when it was determined that full forearm immobilization was no longer necessary, patients were informed of the study, consented, and randomized (as in the flip of a coin) to one of the two study groups using a computerized randomization process that was controlled by the study coordinator. One study group was to consist of patients treated with either sugar tong splint or plaster casting and the other study group was to consist of patients treated with the StabilAir brace. Throughout entire study, the sugar tong splint/casting patients was to be the control group.\n\nPatients were to be asked to return for the following visits after they were randomized:\n\n* 10-14 days post randomization\n* 35 to 42 days (5 to 6 weeks) post randomization\n* 77 to 84 days (11 to 12 weeks) post randomization;\n* And at 12 and 24 months.\n\nAt each visit they were to have x-rays of their wrist and an exam with the physician. In addition, they were to be asked to complete questionnaires regarding their general health, daily activities and pain."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and Females Age ≥ 18 yrs\n* Undisplaced distal radial fractures (with/without ulnar styloid fractures)\n\nExclusion Criteria:\n\n* Age \\< 18 yrs\n* Intra-articular fracture - displaced\n* Loss of reduction after cast or brace treatment\n* Excessive comminution (\\> 50% metophysis)\n* Failed closed reduction (CR) (Unacceptable alignment status post CR: Short \\>2mm; Dorsal angulation \\>0° (neutral), Radial inclination \\< 15°)\n* Ipsilateral ulna fractures (not styloid)\n* Open fracture\n* Senile or dementia or lack of understanding of treatment\n* Previous fracture distal radius\n* Patients with displaced fractures that require pin fixation, external fixation, plate fixation or who qualify for "crystalline injection fracture healing protocol" are excluded from the study'}, 'identificationModule': {'nctId': 'NCT00587795', 'briefTitle': 'Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Orthopedic Study of the Aircast StabilAir Wrist Fracture Brace', 'orgStudyIdInfo': {'id': '228-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'StabilAir Wrist Brace', 'description': 'One study group will consist of patients treated with the StabilAir Wrist Brace.', 'interventionNames': ['Device: StabilAir Wrist Brace']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Study arm will consist of patients that are treated with placement of sugar tong splint or plaster cast.', 'interventionNames': ['Other: Placement of sugar tong splint or plaster cast']}], 'interventions': [{'name': 'StabilAir Wrist Brace', 'type': 'DEVICE', 'description': 'Patient will be placed in a StabilAir Wrist Brace 10-14 days after initial injury and return for follow up visits at 6 weeks; 3, 6, 12 and 24 months.', 'armGroupLabels': ['StabilAir Wrist Brace']}, {'name': 'Placement of sugar tong splint or plaster cast', 'type': 'OTHER', 'otherNames': ['Sugar tong splint or plaster cast'], 'description': 'Patients will receive a sugar tong splint or plaster cast for their wrist fracture. They will return for x-rays and an exam at 6 weeks; 3, 6, 12 and 24 months.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'David G Dennison, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'AirCast LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'David Dennison', 'investigatorAffiliation': 'Mayo Clinic'}}}}