Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
218 participants
INTERVENTIONAL
2024-09-02
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
Definitive fixation by joint fusion
Open Reduction Internal Fixation (ORIF) only
Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
Open Reduction Internal Fixation (ORIF) only
Definitive fixation with plates and screws
Interventions
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Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
Definitive fixation by joint fusion
Open Reduction Internal Fixation (ORIF) only
Definitive fixation with plates and screws
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Joseph R Hsu, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Emory University, Grady Memorial Research Hospital
Atlanta, Georgia, United States
Atrium Health Navicent
Macon, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
Louisiana State University - University Medical Center New Orleans
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
NYC Health and Hospital/Bellevue
New York, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
OrthoCarolina Foot and Ankle Institute
Charlotte, North Carolina, United States
Atrium Health Cabarrus
Concord, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
Prisma Health
Greenville, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The University of Texas Medical Branch
Galveston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Jarrod Dumpe, MD
Role: primary
Matthew Eubank
Role: backup
Carolyn Bridgman
Role: primary
Mark Gage, MD
Role: primary
Nina Fisher, MD
Role: primary
Andrew Chen, MD
Role: primary
Rachel B Seymour, PhD
Role: primary
Christine Churchill, MA
Role: backup
Samuel E Ford, MD
Role: primary
Luke Harmer, MD
Role: primary
Erica Grochowski, MPH
Role: backup
Martha Holden
Role: primary
Kyle Jeray, MD
Role: primary
Bethany Gallagher, MD
Role: primary
Karen Trochez
Role: backup
Joseph Wenke, MD
Role: primary
Other Identifiers
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HT94252310505
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00107954
Identifier Type: -
Identifier Source: org_study_id
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