Primary Subtalar Arthrodesis for Calcaneal Fractures
Part of paid clinical trials in Orange, California.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT06249126
- Status
- Recruiting
Conditions
- Calcaneus Fracture
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) — PROCEDUREDefinitive fixation by joint fusion
- Open Reduction Internal Fixation (ORIF) only — PROCEDUREDefinitive fixation with plates and screws
Study Details
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 Dates
- Start date
- Sep 2, 2024
- Status verified
- May 2026
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 218 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Other: Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)Surgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
- Other: Open Reduction Internal Fixation (ORIF) onlySurgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
Primary Outcome Measure
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score [ Time Frame: Week 6 ]
Central Contacts
- Christine Churchill704-355-6947
Locations (17)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, Irvine | Orange | California | 92868 | John Scolaro, MD (PRINCIPAL_INVESTIGATOR) |
| Emory University, Grady Memorial Research Hospital | Atlanta | Georgia | 30303 | Jason Barron Thomas Large, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Navicent | Macon | Georgia | 31201 | Jarrod Dumpe, MD Adithi Shyam Jarrod Dumpe, MD (PRINCIPAL_INVESTIGATOR) Matthew Martell, DO (SUB_INVESTIGATOR) Sarah Behrens, MD (SUB_INVESTIGATOR) |
| The University of Chicago | Chicago | Illinois | 60637 | Brianna Fram, MD (PRINCIPAL_INVESTIGATOR) |
| University of Kentucky | Lexington | Kentucky | 40536 | Matthew Eubank Paul Matuszewski, MD (PRINCIPAL_INVESTIGATOR) |
| Louisiana State University - University Medical Center New Orleans | New Orleans | Louisiana | 70112 | Carolyn Bridgman Jessica Rivera, MD (PRINCIPAL_INVESTIGATOR) |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | Mark Gage, MD Andrea Howe Mark Gage, MD (PRINCIPAL_INVESTIGATOR) |
| Jamaica Hospital Medical Center | Jamaica | New York | 11418 | Abhishek Ganta, MD (PRINCIPAL_INVESTIGATOR) |
| NYC Health and Hospital/Bellevue | New York | New York | 10016 | Nina Fisher, MD Ivanka Bhambhani Nina Fisher, MD (PRINCIPAL_INVESTIGATOR) |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27546 | Andrew Chen, MD Andrew Chen, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Carolinas Medical Center | Charlotte | North Carolina | 28203 | Rachel B Seymour, PhD Christine Churchill, MA Joseph R Hsu, MD (PRINCIPAL_INVESTIGATOR) Madhav Karunakar, MD (SUB_INVESTIGATOR) Laurence Kempton, MD (SUB_INVESTIGATOR) Suman Medda, MD (SUB_INVESTIGATOR) Kevin Phelps, MD (SUB_INVESTIGATOR) Sarah Pierrie, MD (SUB_INVESTIGATOR) Meghan Wally, PhD (SUB_INVESTIGATOR) Rachel B Seymour, PhD (SUB_INVESTIGATOR) Garrett Bullock, PhD (SUB_INVESTIGATOR) |
| OrthoCarolina Foot and Ankle Institute | Charlotte | North Carolina | 28204 | Samuel E Ford, MD Zach Hutchko Samuel E Ford, MD (PRINCIPAL_INVESTIGATOR) |
| Atrium Health Cabarrus | Concord | North Carolina | 28025 | Luke Harmer, MD Erica Grochowski, MPH Luke Harmer, MD (PRINCIPAL_INVESTIGATOR) Laura Blum, MD (SUB_INVESTIGATOR) |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | 27157 | Martha Holden Jason Halvorson, MD (PRINCIPAL_INVESTIGATOR) |
| Prisma Health | Greenville | South Carolina | 29605 | Kyle Jeray, MD Emily Williams Kyle Jeray, MD (PRINCIPAL_INVESTIGATOR) |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Bethany Gallagher, MD Karen Trochez Bethany Gallagher, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas Medical Branch | Galveston | Texas | 77555 | Joseph Wenke, MD Joseph Wenke, MD (PRINCIPAL_INVESTIGATOR) |
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