About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
Procedure/SurgeryDefinitive fixation by joint fusion
Open Reduction Internal Fixation (ORIF) only
Procedure/SurgeryDefinitive fixation with plates and screws
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Number of Complications
Major complications, including infection, nonunion, malunion, and hardware failure will be captured from the medical record.
Number of Return to Operating Room Visits
Details regarding reoperations will be collected, especially in cases of hardware removal and those randomized to Open Reduction Internal Fixation (ORIF) who receive secondary subtalar fusion.
Number of Resource Utilizations
Healthcare utilization, including new hospitalizations, emergency department visits, clinic visits, imaging, and physical therapy sessions will be documented at all follow-up visits
Rates of Symptomatic Arthritis - Kellgren Lawrence (KL) classification
If post-traumatic osteoarthritis (PTOA) is present, Kellgren Lawrence (KL) classification (This semiquantitative approach primarily evaluates osteophytes and joint space narrowing to assign a score between 0 (no ROA) to 4 (severe ROA) will be assessed by the panel of reviewers and documented.
Sponsors and contacts
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