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NCT06249126NARecruiting

Primary Subtalar Arthrodesis for Calcaneal Fractures

Wake Forest University Health Sciences

Start Date

9/2/2024

Completion Date

12/1/2026

Summary

Management of severe injuries to the heel (displaced intra-articular calcaneus fractures) continues to be a major challenge for orthopedic surgeons. Previous studies have demonstrated poor outcomes, and results show that patients experience long-term pain and decreased quality of life postoperatively. Poor outcomes are driven by pain, in particular, which is linked to post-traumatic subtalar arthritis.

Detailed Description

The goal of this clinical trial is to compare two surgical options for calcaneus fractures to determine best treatment for returning to work sooner in adults. Participants will be randomized to one of two treatment options and will be asked to complete patient reported outcome measure surveys. Researchers will compare Open Reduction and Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) to ORIF alone to see which group returns to work at an earlier timepoint.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Undergoing operative treatment for displaced intra-articular calcaneus fracture * Sanders III and IV displaced intra-articular calcaneus fracture OR Sanders II with any of the following criteria: Bohler angle \< 0 degrees, open fracture, pain syndrome, substance use disorder * Age 18 or older * Able to follow up at site for 1 year Exclusion Criteria: * Planned surgery using extensile lateral approach * Sanders II displaced intra-articular calcaneus fracture without: Bohler angle \< 0 degrees, open fracture, pain syndrome, or substance * \<18 years of age * Body Mass Index (BMI) \>40 * Unable to follow up at site for 1 year * Patients that speak neither English or Spanish * Prisoner

Interventions

PROCEDURE

Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)

PROCEDURE

Open Reduction Internal Fixation (ORIF) only

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Conditions

Calcaneus Fracture

Locations

University of California, Irvine

Orange, California 92868

United States

Emory University, Grady Memorial Research Hospital

Atlanta, Georgia 30303

United States

Atrium Health Navicent

Macon, Georgia 31201

United States

The University of Chicago

Chicago, Illinois 60637

United States

University of Kentucky

Lexington, Kentucky 40536

United States

Louisiana State University - University Medical Center New Orleans

New Orleans, Louisiana 70112

United States

University of Maryland Medical Center

Baltimore, Maryland 21201

United States

Jamaica Hospital Medical Center

Jamaica, New York 11418

United States

NYC Health and Hospital/Bellevue

New York, New York 10016

United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina 27546

United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina 28203

United States

OrthoCarolina Foot and Ankle Institute

Charlotte, North Carolina 28204

United States

Atrium Health Cabarrus

Concord, North Carolina 28025

United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina 27157

United States

Prisma Health

Greenville, South Carolina 29605

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37232

United States

The University of Texas Medical Branch

Galveston, Texas 77555

United States