External Fixation Versus Splinting of Acute Calcaneus Fractures

University of California (UC) Davis

Status: Terminated

Conditions: Calcaneus Fracture

Treatments: Procedure: Splinting; Procedure: External fixator

Study type: Interventional

Funder types: Other

Identifiers

NCT04063657

1436830

Details and patient eligibility

About

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

Enrollment: 1 patient

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntary consent
• Age 18 to 69
• Clinical and/or advanced imaging confirming an acute calcaneal fracture that has occurred within 2 days of which, eventually definitive surgery is recommended/accepted.
• Unable to consent

Exclusion criteria

• Age <18
• Prior surgery of the affected extremity
• Prisoners
• Pregnant women
• Inflammatory arthritis
• Non-English-speaking patients

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1 participants in 2 patient groups

External fixation

Active Comparator group

Description:

Adults diagnosed with an acute (\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in external fixator until the patient is deemed clinically appropriate for definitive surgical fixation.

Treatment:

Procedure: External fixator

Splinting

Active Comparator group

Description:

Adults diagnosed with an acute (\<2 days from injury) calcaneal fracture recommended for operative treatment will be placed in a short leg splint until the patient is deemed clinically appropriate for definitive surgical fixation.

Treatment:

Procedure: Splinting