NCT06249126 Primary Subtalar Arthrodesis for Calcaneal Fractures
| NCT ID | NCT06249126 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Calcaneus Fracture |
| Study Type | INTERVENTIONAL |
| Enrollment | 218 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 218 participants in total. It began in 2024-09-02 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Joseph R Hsu, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT06249126 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Calcaneus Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06249126 currently recruiting?
Yes, NCT06249126 is actively recruiting participants. Contact the research team at Christine.Churchill@advocatehealth.org for enrollment information.
Where is the NCT06249126 trial being conducted?
This trial is being conducted at Orange, United States, Atlanta, United States, Macon, United States, Chicago, United States and 11 additional locations.
Who is sponsoring the NCT06249126 clinical trial?
NCT06249126 is sponsored by Wake Forest University Health Sciences. The principal investigator is Joseph R Hsu, MD at Wake Forest University Health Sciences. The trial plans to enroll 218 participants.