Primary Subtalar Arthrodesis for Calcaneal Fractures

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)

    Procedure/Surgery

    Definitive fixation by joint fusion

  • Open Reduction Internal Fixation (ORIF) only

    Procedure/Surgery

    Definitive fixation with plates and screws

Treatment groups

218 Participants
are divided into 2 treatment groups
Group A: Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)Other 1 intervention
Group B: Open Reduction Internal Fixation (ORIF) onlyOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Week 6
2

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.

Time frame
Week 12
3

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.

Time frame
Month 6
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.

Time frame
Month 12

Secondary outcomes

1

Number of Complications

Major complications, including infection, nonunion, malunion, and hardware failure will be captured from the medical record.

Time frame
Week 6, Months 3 and 6
2

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.

Time frame
Week 6, Months 3 and 6
3

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

Time frame
Week 6, Months 3 and 6
4

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.

Time frame
1 year

Other outcomes

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