NCT06249126

Primary Subtalar Arthrodesis for Calcaneal Fractures

Primary Subtalar Arthrodesis for Calcaneal Fractures to Optimize Performance: A Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Calcaneus Fracture

Interventions

Type	Name	Description
PROCEDURE	Primary Fusion (Open Reduction Internal Fixation (ORIF) + Primary Subtalar Arthrodesis (PSTA)	Definitive fixation by joint fusion
PROCEDURE	Open Reduction Internal Fixation (ORIF) only	Definitive fixation with plates and screws

Timeline

• Start date: 2024-09-02
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-02-08
• Last updated: 2026-04-07

Locations

14 sites across 1 country: United States