Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

NCT02446470 | Unknown

• 1 other identifier: 15-026
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

calcaneus; fracture fixation, internal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Fracture healing

  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

Study Arms (2)

Sinus Tarsi approach

EXPERIMENTAL

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

Procedure: Sinus Tarsi approach

Extensile Lateral approach

ACTIVE COMPARATOR

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

Procedure: Extensile Lateral approach

Interventions

Sinus Tarsi approach 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.

Sinus Tarsi approach

Extensile Lateral approach 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.

Extensile Lateral approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

MeSH Terms

Conditions

Intra-Articular Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Jesse F Doty, MD

  University of Tennessee College of Medicine Chattanooga/Erlanger Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2015
• First Posted: May 18, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: November 29, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)