NCT04063657

External Fixation Versus Splinting of Acute Calcaneus Fractures

External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

Aim: * Determine if external fixation decreases soft tissue complications compared to splinting. * Determine if external fixation decreases time to definitive surgical stabilization and improves final fixation compared to splinting. * Determine if external fixation improves functional outcomes as evaluated by validated functional scoring systems. Hypothesis: * External fixation improves definitive fixation and functional outcomes of acute calcaneal fractures with decreased complication rates compared to splinting

Conditions

• Calcaneus Fracture

Interventions

Type	Name	Description
PROCEDURE	External fixator	Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.
PROCEDURE	Splinting	Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.

Timeline

• Start date: 2019-06-14
• Primary completion: 2019-09-03
• Completion: 2019-09-03
• First posted: 2019-08-21
• Last updated: 2022-02-09
• Results posted: 2022-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study