Primary Subtalar Arthrodesis for Calcaneal Fractures
2 other identifiers
interventional
218
1 country
14
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2024
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2024
CompletedFirst Posted
Study publicly available on registry
February 8, 2024
CompletedStudy Start
First participant enrolled
September 2, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 15, 2025
June 1, 2025
2.2 years
January 30, 2024
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
The primary outcome is return to work/duty as measured by the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. The IPAQ has moderate concordance with accelerometry-measured METs in an orthopaedic injury patient population. (one MET is defined as 3.5 mL O2 uptake/kg per min, which is the resting oxygen uptake in a sitting position). Less than 5 METS is poor, 5-8 METS is fair, 9-11 METS is good, and 12 METS or more is excellent.
Week 6
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
The primary outcome is return to work/duty as measured by the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. The IPAQ has moderate concordance with accelerometry-measured METs in an orthopaedic injury patient population. (one MET is defined as 3.5 mL O2 uptake/kg per min, which is the resting oxygen uptake in a sitting position). Less than 5 METS is poor, 5-8 METS is fair, 9-11 METS is good, and 12 METS or more is excellent.
Week 12
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
The primary outcome is return to work/duty as measured by the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. The IPAQ has moderate concordance with accelerometry-measured METs in an orthopaedic injury patient population. (one MET is defined as 3.5 mL O2 uptake/kg per min, which is the resting oxygen uptake in a sitting position). Less than 5 METS is poor, 5-8 METS is fair, 9-11 METS is good, and 12 METS or more is excellent.
Month 6
Return to Work/Duty - Metabolic Equivalent for Tasks (METs) Score
The primary outcome is return to work/duty as measured by the International Physical Activity Questionnaire (IPAQ). The IPAQ is a validated, self-report measure that captures detailed information about participation in a wide range of physical activities, including the number of days and amount of time spent in the previous 7 days. Responses for each type of physical activity are then transformed into the number of Metabolic Equivalent for Tasks (METs), and a METs/week is calculated for each patient. The IPAQ has moderate concordance with accelerometry-measured METs in an orthopaedic injury patient population. (one MET is defined as 3.5 mL O2 uptake/kg per min, which is the resting oxygen uptake in a sitting position). Less than 5 METS is poor, 5-8 METS is fair, 9-11 METS is good, and 12 METS or more is excellent.
Month 12
Secondary Outcomes (19)
Number of Complications
Week 6, Months 3 and 6
Number of Return to Operating Room Visits
Week 6, Months 3 and 6
Number of Resource Utilizations
Week 6, Months 3 and 6
Rates of Symptomatic Arthritis - Kellgren Lawrence (KL) classification
1 year
Rates of Symptomatic Arthritis - Paley Grading System (PGS)
1 year
- +14 more secondary outcomes
Study Arms (2)
Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
OTHERSurgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
Open Reduction Internal Fixation (ORIF) only
OTHERSurgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
Interventions
Definitive fixation by joint fusion
Definitive fixation with plates and screws
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Emory University, Grady Memorial Research Hospital
Atlanta, Georgia, 30303, United States
Atrium Health Navicent
Macon, Georgia, 31201, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Louisiana State University - University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
NYC Health and Hospital/Bellevue
New York, New York, 10016, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27546, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
OrthoCarolina Foot and Ankle Institute
Charlotte, North Carolina, 28204, United States
Atrium Health Cabarrus
Concord, North Carolina, 28025, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
Prisma Health
Greenville, South Carolina, 29605, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
The University of Texas Medical Branch
Galveston, Texas, 77555, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph R Hsu, MD
Wake Forest University Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2024
First Posted
February 8, 2024
Study Start
September 2, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 15, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share