Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by John Scolaro, MD (uci)

Description

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.

Official Title

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

Details

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.

Keywords

Calcaneus Fracture, heel injuries, post-traumatic subtalar arthritis, orthopaedic injury, Single Person, Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA), Open Reduction Internal Fixation (ORIF) only

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California, Irvine accepting new patients
    Orange California 92868 United States
  • The University of Texas Medical Branch not yet accepting patients
    Galveston Texas 77555 United States
  • University of Kentucky accepting new patients
    Lexington Kentucky 40536 United States

Lead Scientist at University of California Health

  • John Scolaro, MD (uci)
    Associate Clinical Professor, Orthopaedic Surgery, School of Medicine. Authored (or co-authored) 102 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Wake Forest University Health Sciences
ID
NCT06249126
Study Type
Interventional
Participants
Expecting 218 study participants
Last Updated