Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial

Status: Recruiting
Location: See all (16) 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
Alabama
University of Alabama Birmingham
NOT_YET_RECRUITING
Birmingham
Connecticut
Yale University School of Medicine
NOT_YET_RECRUITING
New Haven
Florida
Florida Orthopaedic Institute
NOT_YET_RECRUITING
Temple Terrace
Georgia
Emory University, Grady Memorial Research Hospital
NOT_YET_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
NOT_YET_RECRUITING
Baltimore
North Carolina
University of North Carolina Chapel Hill
NOT_YET_RECRUITING
Chapel Hill
Atrium Health Carolinas Medical Center
RECRUITING
Charlotte
OrthoCarolina Foot and Ankle Institute
NOT_YET_RECRUITING
Charlotte
Atrium Health Cabarrus
RECRUITING
Concord
Atrium Health Wake Forest Baptist
NOT_YET_RECRUITING
Winston-salem
South Carolina
Prisma Health
NOT_YET_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@atriumhealth.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

This content was sourced from clinicaltrials.gov