Recruiting

Subtalar ArthrodesisPrimary Subtalar Arthrodesis for Calcaneal Fractures

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06249126

Conditions

Calcaneus Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Open Reduction Internal Fixation (ORIF) only

Study Details

Brief 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.

Conditions

Calcaneus Fracture

Study ID

NCT06249126

Start date

Sep 2, 2024

Status verified date

May, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

218 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Surgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together

other: Open Reduction Internal Fixation (ORIF) only

Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together

Interventions

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

Definitive fixation by joint fusion

Open Reduction Internal Fixation (ORIF) only

Definitive fixation with plates and screws

Primary outcome measure

Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [ Time Frame: Week 6 ]
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [ Time Frame: Week 12 ]
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [ Time Frame: Month 6 ]
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Christine Churchill

704-355-6947 Christine.Churchill@advocatehealth.org

Locations

University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Susan Demas

714-456-7012 sdemas@hs.uci.edu

Principal Investigator:

John Scolaro, MD

Emory University, Grady Memorial Research Hospital

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Morgan Fuller

404-251-8953 Mrfulle@emory.edu

Jason Barron

jason.barron@emory.edu

Principal Investigator:

Thomas Large, MD

Atrium Health Navicent

Recruiting

Macon, Georgia, United States, 31201

Contacts

Adithi Shyam

adithi.shyam@advocatehealth.org

Principal Investigator:

Jarrod Dumpe, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Paul Matuszewski, MD

859-323-5533 pmatuszewski@uky.edu

Principal Investigator:

Paul Matuszewski, MD

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Andrea Howe

ahowe@som.umaryland.edu

Principal Investigator:

Mark Gage, MD

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27546

Principal Investigator:

Andrew Chen, MD

Atrium Health Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator:

Joseph R Hsu, MD

OrthoCarolina Foot and Ankle Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Zach Hutchko

zachery.hutchko@orthocarolina.com

Principal Investigator:

Samuel E Ford, MD

Atrium Health Cabarrus

Recruiting

Concord, North Carolina, United States, 28025

Principal Investigator:

Luke Harmer, MD

Prisma Health

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Emily Williams

emily.williams8@prismahealth.org

Principal Investigator:

Kyle Jeray, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Bethany Gallagher, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 8, 2026

Last verified

May, 2026

Keywords

heel injuries
post-traumatic subtalar arthritis
orthopaedic injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-08.