Primary Subtalar Arthrodesis for Calcaneal Fractures

Wake Forest University (WFU)

Status: Enrolling

Conditions: Calcaneus Fracture

Treatments: Procedure: Open Reduction Internal Fixation (ORIF) only; Procedure: Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)

Study type: Interventional

Funder types: Other

Identifiers

NCT06249126

IRB00107954

HT94252310505 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The goal of this clinical trial is to compare two surgical options for calcaneus fractures to determine best treatment for returning to work sooner in adults.

Participants will be randomized to one of two treatment options and will be asked to complete patient reported outcome measure surveys.

Researchers will compare Open Reduction and Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA) to ORIF alone to see which group returns to work at an earlier timepoint.

Enrollment: 218 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

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

Other group

Description:

Surgical fixation by joint fusion + Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together

Treatment:

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

Open Reduction Internal Fixation (ORIF) only

Other group

Description:

Surgical fixation with plates and screws, plates, sutures, or rods are used to hold the broken bone together

Treatment:

Procedure: Open Reduction Internal Fixation (ORIF) only