Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-06-26 @ 4:29 AM
Study NCT ID:
NCT04063657
Status:
TERMINATED
Last Update Posted:
2022-02-09
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
External Fixation Versus Splinting of Acute Calcaneus Fractures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016267', 'term': 'External Fixators'}, {'id': 'D013165', 'term': 'Splints'}], 'ancestors': [{'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': 'ckreulen@ucdavis.edu', 'phone': '(916) 734-6805', 'title': 'Dr. Christopher Kreulen', 'organization': 'University of California, Davis'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled.'}}, 'adverseEventsModule': {'timeFrame': '24 months', 'description': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant was lost to follow-up and did not attend follow up visits.', 'eventGroups': [{'id': 'EG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Definitive Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 2 weeks from injury', 'description': 'Duration of time from injury to definitive surgery', 'unitOfMeasure': 'days', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 subject was enrolled.'}, {'type': 'PRIMARY', 'title': 'Soft Tissue Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2 weeks after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'PRIMARY', 'title': 'Soft Tissue Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 6 weeks after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'PRIMARY', 'title': 'Soft Tissue Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 12 weeks after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'PRIMARY', 'title': 'Soft Tissue Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 6 months after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'PRIMARY', 'title': 'Soft Tissue Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 12 months after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'PRIMARY', 'title': 'Soft Tissue Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 24 months after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Union Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.', 'description': 'Assessment of fracture healing', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': "Radiographic Parameters - Bohler's Angle", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': "Bohler's angle", 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Radiographic Parameters - Calcaneal Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Calcaneal height', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Radiographic Parameters - Angle of Gissan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Angle of Gissan', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Radiographic Parameters - Calcaneal Width', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Calcaneal width', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Radiographic Parameters - Calcaneal Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Calcaneal length', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Functional Outcomes - VAS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.', 'description': 'Assess Visual Analogue pain score(VAS). This will be a patient reported measure from 0-10, minimum score of 0 (no pain), maximum score of 10 (most pain).', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Functional Outcomes - FFI-R', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Revised foot function index questionnaire (FFI-R) will assess patient pain, stiffness, activity, difficulties with ambulation, and social issues. The score is tabulated from 34 questions answered 1-5 (1= none of the time, 5= All of the time, scale 34-170). Higher scores indicate worse outcomes.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Functional Outcomes - FAAM ADL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Foot and Ankle Ability measure activities of daily living (FAAM ADL) is a 21-item activities assessing the patient\'s functionality related to their activities of daily living. The response to each item is scored from 4 to 0, with 4 being \'\'no difficulty\'\' and 0 being \'\'unable to do." Scale 0-84. Higher scores indicate a more favorable functional level.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}, {'type': 'SECONDARY', 'title': 'Functional Outcomes - FAAM Sport', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'OG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Foot and Ankle Ability measure activities of daily living (FAAM Sport) is a 8-item questionnaire assess the patient\'s ability to participate in athletic activities. The response to each item is scored from 4 to 0, with 4 being \'\'no difficulty\'\' and 0 being \'\'unable to do." Scale 0-32. Higher scores indicate a more favorable functional level.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study stopped prematurely due to poor recruitment. Only 1 participant was enrolled. Participant did not attend follow up visit where this data would have been collected.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'FG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}], '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': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'External Fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nExternal fixator: Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'BG001', 'title': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.\n\nSplinting: Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '50'}, {'value': '50', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '50'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'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': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', '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'}], 'populationDescription': 'Study stopped prematurely, only 1 participant enrolled in the external fixation arm.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-02', 'size': 363579, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-12T16:48', 'hasProtocol': True}, {'date': '2019-06-14', 'size': 289294, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-01-12T16:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'whyStopped': 'Study was slow to recruit. PI decided to close study to focus on other trials.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-12', 'studyFirstSubmitDate': '2019-08-07', 'resultsFirstSubmitDate': '2022-01-12', 'studyFirstSubmitQcDate': '2019-08-19', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-12', 'studyFirstPostDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Definitive Surgery', 'timeFrame': 'Within 2 weeks from injury', 'description': 'Duration of time from injury to definitive surgery'}, {'measure': 'Soft Tissue Complications', 'timeFrame': 'Assessed at 2 weeks after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage'}, {'measure': 'Soft Tissue Complications', 'timeFrame': 'Assessed at 6 weeks after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage'}, {'measure': 'Soft Tissue Complications', 'timeFrame': 'Assessed at 12 weeks after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage'}, {'measure': 'Soft Tissue Complications', 'timeFrame': 'Assessed at 6 months after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage'}, {'measure': 'Soft Tissue Complications', 'timeFrame': 'Assessed at 12 months after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage'}, {'measure': 'Soft Tissue Complications', 'timeFrame': 'Assessed at 24 months after surgery', 'description': 'Incidence of infection, dehiscence and need for soft tissue coverage'}], 'secondaryOutcomes': [{'measure': 'Union Rate', 'timeFrame': 'Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.', 'description': 'Assessment of fracture healing'}, {'measure': "Radiographic Parameters - Bohler's Angle", 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': "Bohler's angle"}, {'measure': 'Radiographic Parameters - Calcaneal Height', 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Calcaneal height'}, {'measure': 'Radiographic Parameters - Angle of Gissan', 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Angle of Gissan'}, {'measure': 'Radiographic Parameters - Calcaneal Width', 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Calcaneal width'}, {'measure': 'Radiographic Parameters - Calcaneal Length', 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Calcaneal length'}, {'measure': 'Functional Outcomes - VAS', 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.', 'description': 'Assess Visual Analogue pain score(VAS). This will be a patient reported measure from 0-10, minimum score of 0 (no pain), maximum score of 10 (most pain).'}, {'measure': 'Functional Outcomes - FFI-R', 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Revised foot function index questionnaire (FFI-R) will assess patient pain, stiffness, activity, difficulties with ambulation, and social issues. The score is tabulated from 34 questions answered 1-5 (1= none of the time, 5= All of the time, scale 34-170). Higher scores indicate worse outcomes.'}, {'measure': 'Functional Outcomes - FAAM ADL', 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Foot and Ankle Ability measure activities of daily living (FAAM ADL) is a 21-item activities assessing the patient\'s functionality related to their activities of daily living. The response to each item is scored from 4 to 0, with 4 being \'\'no difficulty\'\' and 0 being \'\'unable to do." Scale 0-84. Higher scores indicate a more favorable functional level.'}, {'measure': 'Functional Outcomes - FAAM Sport', 'timeFrame': 'Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery', 'description': 'Foot and Ankle Ability measure activities of daily living (FAAM Sport) is a 8-item questionnaire assess the patient\'s ability to participate in athletic activities. The response to each item is scored from 4 to 0, with 4 being \'\'no difficulty\'\' and 0 being \'\'unable to do." Scale 0-32. Higher scores indicate a more favorable functional level.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Staged External Fixation', 'Splinting', 'Soft tissue complications'], 'conditions': ['Calcaneus Fracture']}, 'descriptionModule': {'briefSummary': 'Aim:\n\n* Determine if external fixation decreases soft tissue complications compared to splinting.\n* Determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting.\n* Determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems.\n\nHypothesis:\n\n* External fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary consent\n* Age 18 to 69\n* Clinical and/or advanced imaging confirming an acute calcaneal fracture that has occurred within 2 days of which, eventually definitive surgery is recommended/accepted.\n* Unable to consent\n\nExclusion Criteria:\n\n* Age \\<18\n* Prior surgery of the affected extremity\n* Prisoners\n* Pregnant women\n* Inflammatory arthritis\n* Non-English-speaking patients'}, 'identificationModule': {'nctId': 'NCT04063657', 'briefTitle': 'External Fixation Versus Splinting of Acute Calcaneus Fractures', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery', 'orgStudyIdInfo': {'id': '1436830'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'External fixation', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.', 'interventionNames': ['Procedure: External fixator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Splinting', 'description': 'Adults diagnosed with an acute (\\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.', 'interventionNames': ['Procedure: Splinting']}], 'interventions': [{'name': 'External fixator', 'type': 'PROCEDURE', 'description': 'Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.', 'armGroupLabels': ['External fixation']}, {'name': 'Splinting', 'type': 'PROCEDURE', 'description': 'Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.', 'armGroupLabels': ['Splinting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Christopher D Kreulen, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}