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Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

NCT02446470 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2018-11-29

No results posted yet for this study

Summary

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.

Conditions

  • Intra-articular Fractures

Interventions

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.

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.

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Jesse F Doty, MD · University of Tennessee College of Medicine Chattanooga/Erlanger Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02446470 on ClinicalTrials.gov