Comparative Study of Fixation or Fusion of Calcaneal Fractures

Study Overview
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Brief Summary
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A multicentre randomized controlled trial that will be conducted at Level 1 trauma centres across Canada. It will compare patients who receive open reduction, internal fixation for Sanders IV calcaneal fractures to patients who receive primary subtalar fusion for the same type of fracture. Patients will be followed up for a period of two years from the time of operation with evaluations being performed at 5 time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Official Title
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A Prospective Randomized Multicentre Clinical Trial Comparing Open Reduction Internal Fixation With Primary Subtalar Fusion in Patients With Severely Comminuted (Sanders IV), Displaced, Intra-articular Fractures of the Calcaneus

Conditions
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Fractures, Comminuted, Fracture Fixation, Internal

Intervention / Treatment
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* Procedure: Open reduction internal fixation
* Procedure: Fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with Sanders IV displaced intra-articular calcaneal fracture males and females aged 16-59 inclusive ability to provide informed consent available for follow-up for at least 2 years after injury Exclusion Criteria: medical contraindications to surgery previous calcaneal pathology (infection, tumor, etc) co-existent foot or ipsilateral lower limb injury open calcaneal fracture injury greater than 3 weeks old head injured patients inability to obtain pre-operative CT scan or accurately classify the fractures according to the Sanders classification system inability to comply with advice to diminish smoking after the injury metal allergy extremely comminuted intra-articular fractures of the calcaneus deemed impossible to reconstruct by the treating surgeon any concerns either by the treating surgeon or patient about harvesting autograft needed for fusion

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 59 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 |
| --- | --- |
| Other: Fix<br>Open reduction internal fixation of severely comminuted calcaneal fracture (Sanders IV) | Procedure: Open reduction internal fixation<br>* Open reduction internal fixation surgery of severely comminuted calcaneal fracture (Sanders IV).<br>|
| Other: Fuse<br>Primary subtalar fusion of severely comminuted calcaneal fractures (Sanders IV). | Procedure: Fusion<br>* Primary subtalar fusion of severely comminuted calcaneal fracture (Sanders IV)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Health Survey - SF-36 |  | 6 months, 12 months, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validated Visual Analogue Scale |  | 6 months, 12 months, and 24 months | 
| Musculoskeletal Function Assessment |  | 6 months, 12 months, and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Calcaneus, Intra-articular fracture, open reduction internal fixation, primary subtalar fusion