External Fixation Versus Splinting of Acute Calcaneus Fractures
NCT ID: NCT04063657
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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TERMINATED
NA
1 participants
INTERVENTIONAL
2019-06-14
2019-09-03
Brief Summary
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* Determine if external fixation decreases soft tissue complications compared to splinting.
* Determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting.
* Determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems.
Hypothesis:
* External fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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External fixation
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.
External 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.
Splinting
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.
Splinting
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.
Interventions
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External 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.
Splinting
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.
Eligibility Criteria
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Inclusion Criteria
* Age 18 to 69
* Clinical and/or advanced imaging confirming an acute calcaneal fracture that has occurred within 2 days of which, eventually definitive surgery is recommended/accepted.
* Unable to consent
Exclusion Criteria
* Prior surgery of the affected extremity
* Prisoners
* Pregnant women
* Inflammatory arthritis
* Non-English-speaking patients
18 Years
69 Years
ALL
No
Sponsors
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University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Christopher D Kreulen, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center
Locations
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University of California, Davis Medical Center
Sacramento, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1436830
Identifier Type: -
Identifier Source: org_study_id
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