Primary Subtalar Arthrodesis for Calcaneal Fractures
This study is looking for adults aged 18 and older who have severe heel bone (calcaneus) fractures that need surgery. The goal is to compare two surgical methods to see which one helps people return to work sooner. Researchers will compare Open Reduction Internal Fixation (ORIF) combined with Primary Subtalar Arthrodesis (PSTA) – which is a joint fusion – against ORIF alone, which uses plates and screws to fix the bone. The study aims to find out which approach leads to an earlier return to work or daily activities. You can join if you have a specific type of heel fracture (Sanders III and IV, or Sanders II with certain other conditions) and can attend follow-up appointments for one year. The study is currently unclear on its recruitment status and plans to enroll 218 participants.
- Study design
- This is an interventional study where participants will be randomly assigned to one of two treatment groups. It plans to enroll 218 participants.
- What's involved
- Participants will undergo one of two surgical procedures and complete surveys about their recovery. You will need to follow up at the study site for one year.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year after treatment, with specific measurements taken at 6 and 12 weeks, and at 6 months.
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Primary Subtalar Arthrodesis for Calcaneal Fractures
At a glance
Conditions
NCT06249126
Where you'd take part
This study runs at 17 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Atrium Health Navicent
Macon, Georgiastudy coordinator listed
Recruiting
Emory University, Grady Memorial Research Hospital
Atlanta, Georgiastudy coordinator listed
Recruiting
Jamaica Hospital Medical Center
Jamaica, New Yorkstudy coordinator listed
Not yet recruiting
NYC Health and Hospital/Bellevue
New York, New Yorkstudy coordinator listed
Not yet recruiting
OrthoCarolina Foot and Ankle Institute
Charlotte, North Carolinastudy coordinator listed
Recruiting
Prisma Health
Greenville, South Carolinastudy coordinator listed
Recruiting
The University of Chicago
Chicago, Illinoisstudy coordinator listed
Not yet recruiting
University of California, Irvine
Orange, Californiastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Joseph R Hsu, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences
Who to contact
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Inclusion
Exclusion
What this trial measures
- Return to Work/Duty - Metabolic Equivalent for Tasks (METs) ScoreWeek 6
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.
- Return to Work/Duty - Metabolic Equivalent for Tasks (METs) ScoreWeek 12
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.
- Return to Work/Duty - Metabolic Equivalent for Tasks (METs) ScoreMonth 6
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.
- Return to Work/Duty - Metabolic Equivalent for Tasks (METs) ScoreMonth 12
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.