Clinical Trials Directory

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UnknownNCT02446470

Sinus Tarsi Versus Extensile Lateral Approach for Calcaneus Fractures

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
110 (estimated)
Sponsor
University of Tennessee · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDURESinus Tarsi approachA 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.
PROCEDUREExtensile Lateral approachAn 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.

Timeline

Start date
2015-05-01
Primary completion
2019-12-01
Completion
2019-12-01
First posted
2015-05-18
Last updated
2018-11-29

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02446470. Inclusion in this directory is not an endorsement.