External Fixation Versus Splinting of Acute Calcaneus Fractures

Study Overview
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Brief Summary
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Aim: 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

Official Title
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External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery

Conditions
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Calcaneus Fracture

Intervention / Treatment
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* Procedure: External fixator
* Procedure: Splinting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Voluntary consent 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: Age <18 Prior surgery of the affected extremity Prisoners Pregnant women Inflammatory arthritis Non-English-speaking patients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: External fixation<br>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. | Procedure: External fixator<br>* 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.<br>|
| Active Comparator: Splinting<br>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. | Procedure: Splinting<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Definitive Surgery | Duration of time from injury to definitive surgery | Within 2 weeks from injury | 
| Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | Assessed at 2 weeks after surgery | 
| Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | Assessed at 6 weeks after surgery | 
| Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | Assessed at 12 weeks after surgery | 
| Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | Assessed at 6 months after surgery | 
| Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | Assessed at 12 months after surgery | 
| Soft Tissue Complications | Incidence of infection, dehiscence and need for soft tissue coverage | Assessed at 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Union Rate | Assessment of fracture healing | Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year. | 
| Radiographic Parameters - Bohler's Angle | Bohler's angle | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | 
| Radiographic Parameters - Calcaneal Height | Calcaneal height | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | 
| Radiographic Parameters - Angle of Gissan | Angle of Gissan | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | 
| Radiographic Parameters - Calcaneal Width | Calcaneal width | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | 
| Radiographic Parameters - Calcaneal Length | Calcaneal length | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | 
| Functional Outcomes - VAS | 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). | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery. | 
| Functional Outcomes - FFI-R | 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. | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | 
| Functional Outcomes - FAAM ADL | 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. | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | 
| Functional Outcomes - FAAM Sport | 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. | Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Staged External Fixation, Splinting, Soft tissue complications