Primary Subtalar Arthrodesis for Calcaneal Fractures
United States218 participantsStarted 2024-09-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing primary subtalar arthrodesis — meaning fusing the joint right away after the fracture — versus the usual approach of fixing the bone first and potentially fusing later; can you explain what that difference means for my long-term foot function and recovery?
2The trial is measuring success mainly by how well patients return to work or physical activity using something called a METs score — given my specific job and activity level, how likely is it that this outcome measure would actually reflect what matters most to me?
3Since this trial doesn't have a traditional phase number, which usually signals where something is in safety testing, what is already known about the safety of primary subtalar fusion compared to standard calcaneal fracture repair, and are there risks I should specifically be aware of?
4Would I be a realistic candidate to discuss for this trial, and are there other standard treatment options I should consider first before thinking about whether a study like this might be worth exploring with my care team?
5This trial is still recruiting, so results aren't in yet — how would you weigh the uncertainty of enrolling in an ongoing study against pursuing the more established treatment pathway for my type of calcaneal fracture?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
Timeframe: Week 6
2
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
Timeframe: Week 12
3
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
Timeframe: Month 6
4
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score