Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Georgia
Emory University, Grady Memorial Research Hospital
RECRUITING
Atlanta
Atrium Health Navicent
RECRUITING
Macon
Kentucky
University of Kentucky
NOT_YET_RECRUITING
Lexington
Louisiana
Louisiana State University - University Medical Center New Orleans
NOT_YET_RECRUITING
New Orleans
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
North Carolina
University of North Carolina Chapel Hill
RECRUITING
Chapel Hill
Atrium Health Carolinas Medical Center
RECRUITING
Charlotte
OrthoCarolina Foot and Ankle Institute
RECRUITING
Charlotte
Atrium Health Cabarrus
RECRUITING
Concord
Atrium Health Wake Forest Baptist
NOT_YET_RECRUITING
Winston-salem
New York
NYC Health and Hospital/Bellevue
NOT_YET_RECRUITING
New York
South Carolina
Prisma Health
RECRUITING
Greenville
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Texas
The University of Texas Medical Branch
NOT_YET_RECRUITING
Galveston
Contact Information
Primary
Christine Churchill
Christine.Churchill@advocatehealth.org
704-355-6947
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2026-12
Participants
Target number of participants: 218
Treatments
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) only
Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences