Primary Subtalar Arthrodesis for Calcaneal Fractures
ConditionCalcaneus Fracture
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
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
Treatments tested in this trial
- Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)
- Open Reduction Internal Fixation (ORIF) only
Treatment groups
218 Participants
are divided into 2 treatment groupsLocations
17California
University of California, Irvine92868, Orange United States
Georgia
Emory University, Grady Memorial Research Hospital30303, Atlanta United States
Atrium Health Navicent31201, Macon United States
Illinois
The University of Chicago60637, Chicago United States
Sponsors and collaborators
Wake Forest University Health Sciences
Lead sponsor
Source ClinicalTrials.gov