MedTrace Logo

External Fixation Versus Splinting of Acute Calcaneus Fractures

NCT04063657 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-02-09

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Christopher D Kreulen, MD, MS · Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-14
Primary Completion
2019-09-03
Completion
2019-09-03
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04063657 on ClinicalTrials.gov