Primary Subtalar Arthrodesis for Calcaneal Fractures

Recruiting now · Not applicable

Conditions studied: Calcaneus Fracture

In brief

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.

Key facts

Study ID

NCT06249126

Run by

Wake Forest University Health Sciences

People needed

218

Starts

2024-09-02

Expected to finish

2026-12-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• OrthoCarolina Foot and Ankle Institute — Charlotte, North Carolina, United States (enrolling)
• Atrium Health Cabarrus — Concord, North Carolina, United States (enrolling)
• Atrium Health Navicent — Macon, Georgia, United States (enrolling)
• Prisma Health — Greenville, South Carolina, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• University of California, Irvine — Orange, California, United States (enrolling)
• University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
• Emory University, Grady Memorial Research Hospital — Atlanta, Georgia, United States (enrolling)
• University of Kentucky — Lexington, Kentucky, United States (enrolling)
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Atrium Health Carolinas Medical Center — Charlotte, North Carolina, United States (enrolling)
• The University of Texas Medical Branch — Galveston, Texas, United States
• The University of Chicago — Chicago, Illinois, United States
• Louisiana State University - University Medical Center New Orleans — New Orleans, Louisiana, United States
• Jamaica Hospital Medical Center — Jamaica, New York, United States
• NYC Health and Hospital/Bellevue — New York, New York, United States
• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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