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 groupsSponsors and collaborators
Source ClinicalTrials.gov