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Primary Subtalar Arthrodesis for Calcaneal Fractures

Recruiting

Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial

Who can join

Ages 18 and older · All sexes

Full eligibility criteria

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

About the study

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.

What is being tested

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

Sponsor: Wake Forest University Health Sciences · Participants: 218 · Started: Sep 2, 2024

Contact the study team

Christine Churchill · Phone: 704-355-6947

Official record on ClinicalTrials.gov — NCT06249126

Locations in the U.S.

California	University of California, Irvine, Orange
Georgia	Emory University, Grady Memorial Research Hospital, Atlanta Atrium Health Navicent, Macon
Illinois	The University of Chicago, Chicago (Not yet recruiting)
Kentucky	University of Kentucky, Lexington
Louisiana	Louisiana State University - University Medical Center New Orleans, New Orleans (Not yet recruiting)
Maryland	University of Maryland Medical Center, Baltimore
New York	Jamaica Hospital Medical Center, Jamaica (Not yet recruiting) NYC Health and Hospital/Bellevue, New York (Not yet recruiting)
North Carolina	University of North Carolina Chapel Hill, Chapel Hill Atrium Health Carolinas Medical Center, Charlotte OrthoCarolina Foot and Ankle Institute, Charlotte Atrium Health Cabarrus, Concord Atrium Health Wake Forest Baptist, Winston-Salem (Not yet recruiting)
South Carolina	Prisma Health, Greenville
Tennessee	Vanderbilt University Medical Center, Nashville
Texas	The University of Texas Medical Branch, Galveston (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.