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Subtalar Arthrodesis for Calcaneus Fractures

N/A
Waitlist Available
Led By Joseph R Hsu, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Sanders II displaced intra-articular calcaneus fracture without: Bohler angle < 0 degrees, open fracture, pain syndrome, or substance
<18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Summary

This trial shows that treating severe heel injuries remains difficult for orthopedic surgeons. Previous studies have shown that patients often have long-term pain and reduced quality of life after surgery due to post-traumatic subt

Who is the study for?
This trial is for adults over 18 with severe heel bone fractures (Sanders III/IV or Sanders II with specific complications). Participants must be undergoing surgery, able to attend follow-ups for a year, and speak English or Spanish. It's not for those using certain surgical methods, under 18, very overweight (BMI >40), unable to commit to follow-up visits, or prisoners.
What is being tested?
The study compares two surgical treatments for serious heel injuries: one group receives both an open reduction internal fixation (ORIF) and primary subtalar arthrodesis (PSTA), while the other gets only ORIF. The goal is to see which method better reduces long-term pain and improves quality of life.
What are the potential side effects?
Potential side effects may include pain at the surgery site, infection risks from the operation, possible nerve damage leading to numbness or tingling sensations in the foot area, joint stiffness or arthritis development in adjacent joints due to altered mechanics.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am having surgery for a broken heel bone that affects the joint.
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I have a severe heel bone fracture with specific complications.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My heel bone is fractured but doesn't have severe complications.
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I am under 18 years old.
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I do not speak English or Spanish.
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My surgery will be done through a large side incision.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
Secondary study objectives
Counter-Movement Jump - Height
Counter-Movement Jump - force development (percent body weight/milliseconds)
Counter-Movement Jump - force dissipation (percent body weight/milliseconds)
+16 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)Experimental Treatment1 Intervention
Surgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
Group II: Open Reduction Internal Fixation (ORIF) onlyExperimental Treatment1 Intervention
Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,266 Previous Clinical Trials
1,013,489 Total Patients Enrolled
Joseph R Hsu, MDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
50 Total Patients Enrolled
~145 spots leftby Dec 2026
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