Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

University of Tennessee

Status: Unknown

Conditions: Intra-articular Fractures

Treatments: Procedure: Sinus Tarsi approach; Procedure: Extensile Lateral approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02446470

15-026

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Sinus Tarsi approach

Experimental group

Description:

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

Treatment:

Procedure: Sinus Tarsi approach

Extensile Lateral approach

Active Comparator group

Description:

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

Treatment:

Procedure: Extensile Lateral approach