Sponsor study identifier
Secondary identifiers
OTHER · Department of Defense
interventional
218
1 country
17
Study Start
September 2, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2024
Actual (reported)February 8, 2024
Actual (reported)September 2, 2024
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
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
Surgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together
Definitive fixation by joint fusion
Definitive fixation with plates and screws
University of California, Irvine
Orange, California, 92868, United States
Emory University, Grady Memorial Research Hospital
Atlanta, Georgia, 30303, United States
Joseph R Hsu, MD
Wake Forest University Health Sciences
First Submitted
January 30, 2024
First Posted
February 8, 2024
Study Start
September 2, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Atrium Health Navicent
Macon, Georgia, 31201, United States
The University of Chicago
Chicago, Illinois, 60637, 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
Jamaica Hospital Medical Center
Jamaica, New York, 11418, 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
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 8, 2026
Record last verified: 2026-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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