Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

Intra-articular Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02446470
• Other study ID #: 15-026
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2019

Study information

• Verified date: November 2018
• Source: University of Tennessee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Intra-Articular Fractures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Erlanger Health System	Chattanooga	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee

Country where clinical trial is conducted

United States, 

Outcome

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