Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

NCT ID: NCT02446470

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sinus Tarsi approach

The Sinus Tarsi approach is the surgical approach for the incision.

Group Type: EXPERIMENTAL

Sinus Tarsi approach

Intervention Type: PROCEDURE

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.

Extensile Lateral approach

The Extensile Lateral approach is the surgical approach for the incision.

Group Type: ACTIVE_COMPARATOR

Extensile Lateral approach

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Tennessee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jesse F Doty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee College of Medicine Chattanooga/Erlanger Health System

Locations

Erlanger Health System

Chattanooga, Tennessee, United States

Countries

United States

Other Identifiers

15-026

Identifier Type: -

Identifier Source: org_study_id