Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

Not Applicable

• Conditions: Intra-articular Fractures
• Interventions: Procedure: Sinus Tarsi approach; Procedure: Extensile Lateral approach

• Registration Number: NCT02446470
• Lead Sponsor: University of Tennessee

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-30
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-27
• Last Update Posted: 2018-11-29
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sinus Tarsi approach	Sinus Tarsi approach	The Sinus Tarsi approach is the surgical approach for the incision.
Extensile Lateral approach	Extensile Lateral approach	The Extensile Lateral approach is the surgical approach for the incision.

Primary Outcome Measures

Name	Time	Method
Wound complication rate	approximately one year	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Erlanger Health System; 🇺🇸 Chattanooga, Tennessee, United States