Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial
Wake Forest University Health Sciences
Summary
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 In…
Interventions
- ProcedurePrimary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
Definitive fixation by joint fusion
- ProcedureOpen Reduction Internal Fixation (ORIF) only
Definitive fixation with plates and screws
Locations (14)
- Emory University, Grady Memorial Research HospitalAtlanta, Georgia
- Atrium Health NavicentMacon, Georgia
- University of KentuckyLexington, Kentucky
- Louisiana State University - University Medical Center New OrleansNew Orleans, Louisiana
- University of Maryland Medical CenterBaltimore, Maryland
- NYC Health and Hospital/BellevueNew York, New York