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Primary Subtalar Arthrodesis for Calcaneal Fractures

Primary Subtalar Arthrodesis for Calcaneal Fractures

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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

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 details
    Calcaneus Fracture

NCT06249126

Wake Forest University Health Sciences

11 June 2025

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