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Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06249126
Study type Interventional
Source Wake Forest University Health Sciences
Contact Christine Churchill
Phone 704-355-6947
Email Christine.Churchill@atriumhealth.org
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date December 2026

See also
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Recruiting NCT05555459 - Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation N/A
Completed NCT04509895 - Minimally Invasive Calcaneal Fracture Fixation vs Standard Lateral Approach N/A
Completed NCT02609347 - Manual Therapy After Ankle/Hindfoot Fractures N/A
Recruiting NCT04372251 - Osteosynthesis of Intraarticular Calcaneal Fractures: Arthroscopically Assisted Percutaneous Technique Versus Sinus Tarsi Approach N/A
Terminated NCT04063657 - External Fixation Versus Splinting of Acute Calcaneus Fractures N/A
Completed NCT04070274 - A New Surgery Platform for Calcaneal Surgery: a Clinical Research N/A
Not yet recruiting NCT05721378 - Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures N/A
Completed NCT06234358 - A Clinical Study Carried Out in Patients Operated With Calcanail®
Not yet recruiting NCT03572816 - Heel-unloading Orthosis for Treatment of Calcaneus Fractures N/A