Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

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

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.

Study Overview

• Status: Unknown
• Conditions: Intra-articular Fractures
• Intervention / Treatment: Procedure: Sinus Tarsi approach; Procedure: Extensile Lateral approach

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Erlanger Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sinus Tarsi approach; The Sinus Tarsi approach is the surgical approach for the incision.	Procedure: Sinus Tarsi approach; 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.
Active Comparator: Extensile Lateral approach; The Extensile Lateral approach is the surgical approach for the incision.	Procedure: Extensile Lateral approach; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Tennessee

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: April 30, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 27, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: calcaneus; fracture fixation, internal
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Intra-Articular Fractures
• Other Study ID Numbers: 15-026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO