Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

Study Overview
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Brief Summary
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This study is a prospective, randomized controlled trial comparing the sinus tarsi approach to the extensile lateral approach for surgical fixation of calcaneus fractures. It is hypothesized that open reduction and internal fixation of intra-articular calcaneus fractures using a sinus tarsi approach will provide equivalent fracture reduction and stable fixation with significantly decreased wound complication rates in comparison to an extensile lateral approach.

Official Title
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Sinus Tarsi Versus Extensile Lateral Approach for Open Reduction Internal Fixation of Intra-articular Calcaneus Fractures

Conditions
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Intra-articular Fractures

Intervention / Treatment
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* Procedure: Sinus Tarsi approach
* Procedure: Extensile Lateral approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Skeletally mature patients ≥ 18 years of age Closed intra-articular calcaneus fractures Undergoing surgical fixation (CPT code 28415) Ability to understand and agree to informed consent Exclusion Criteria: Patients < 18 years of age Open fractures Dislocations that require open reduction Previous calcaneus abnormality or injury Unable to understand or agree to informed consent

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Sinus Tarsi approach<br>The Sinus Tarsi approach is the surgical approach for the incision. | Procedure: Sinus Tarsi approach<br>* A straight incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal which centers the incision over the sinus tarsi. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis (EDB). The origin of EDB is identified and the muscle is released distal enough to fully visualize the fracture and articular surface of the calcaneus. Following exposure of the fracture and articular surface of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern.<br>|
| Active Comparator: Extensile Lateral approach<br>The Extensile Lateral approach is the surgical approach for the incision. | Procedure: Extensile Lateral approach<br>* An L-shaped incision overlying the lateral wall of the calcaneus will be made, followed by sharp dissection of soft tissues in line with the skin incision down to the periosteum. Effort will be made to identify and protect the sural nerve, as it commonly crosses the surgical field with this approach. The soft tissue flap is retracted as a single unit as subperiosteal dissection is performed. Following exposure of the lateral wall of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound complication rate | There is an expected wound complication rate of up to 30% with this type of fracture. The difference in wound complication rate between the two surgical approaches will be the primary outcome measure. Wound complications will be defined by the presence of superficial or deep infections, skin edge necrosis, and soft tissue sloughing. | approximately one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture healing | On radiographic and clinical exam | approximately one year | 
| Rate of sural nerve injury |  | approximately one year | 
| Rate of peroneal tendon injury |  | approximately one year | 
| Change in operative time |  | one day | 
| Rate of secondary surgery |  | approximately one year | 
| Visual Analog Scale | Pain Score | approximately one year | 
| American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale | Functional Outcome Score | approximately one year | 
| Foot Function Index | Functional Outcome Score | approximately one year | 
| Short-Form 36 (SF-36) Health Survey | Functional Outcome Score | approximately one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcaneus, fracture fixation, internal