RecruitingNot ApplicableNCT06249126

Primary Subtalar Arthrodesis for Calcaneal Fractures

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


Sponsor

Wake Forest University Health Sciences

Enrollment

218 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

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

Definitive fixation by joint fusion

PROCEDUREOpen Reduction Internal Fixation (ORIF) only

Definitive fixation with plates and screws


Locations(14)

Emory University, Grady Memorial Research Hospital

Atlanta, Georgia, United States

Atrium Health Navicent

Macon, Georgia, United States

University of Kentucky

Lexington, Kentucky, United States

Louisiana State University - University Medical Center New Orleans

New Orleans, Louisiana, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

NYC Health and Hospital/Bellevue

New York, New York, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

OrthoCarolina Foot and Ankle Institute

Charlotte, North Carolina, United States

Atrium Health Cabarrus

Concord, North Carolina, United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Prisma Health

Greenville, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

The University of Texas Medical Branch

Galveston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06249126


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