Surgical options for treating severe heel fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare two surgical approaches for managing displaced intra-articular calcaneus fractures, which are severe injuries to the heel. Participants will be randomly assigned to receive either Open Reduction and Internal Fixation (ORIF) combined with Primary Subtalar Arthrodesis (PSTA) or ORIF alone. The primary focus is to evaluate which treatment allows patients to return to work sooner, with participants completing patient-reported outcome measures to assess their recovery. The study seeks to address the challenges of poor postoperative outcomes and long-term pain associated with these fractures.

Why it matters

Who can join: the full rules

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

Where it's running

• University of California, Irvine
  Orange, California, United States Recruiting
• Emory University, Grady Memorial Research Hospital
  Atlanta, Georgia, United States Recruiting
• Atrium Health Navicent
  Macon, Georgia, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• University of Maryland Medical Center
  Baltimore, Maryland, United States Recruiting
• University of North Carolina Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Joseph R Hsu, MD — Wake Forest University Health Sciences
• Study coordinator: Christine Churchill
• Email: Christine.Churchill@advocatehealth.org
• Phone: 704-355-6947

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.