External Fixation Versus Splinting of Acute Calcaneus Fractures

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

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

Study Overview

• Status: Terminated
• Conditions: Calcaneus Fracture
• Intervention / Treatment: Procedure: External fixator; Procedure: Splinting

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: External fixation; 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.	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.
Active Comparator: Splinting; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Definitive Surgery	Duration of time from injury to definitive surgery	Within 2 weeks from injury
Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 2 weeks after surgery
Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 6 weeks after surgery
Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 12 weeks after surgery
Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 6 months after surgery
Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 12 months after surgery
Soft Tissue Complications	Incidence of infection, dehiscence and need for soft tissue coverage	Assessed at 24 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Union Rate	Assessment of fracture healing	Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.
Radiographic Parameters - Bohler's Angle	Bohler's angle	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Height	Calcaneal height	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Angle of Gissan	Angle of Gissan	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Width	Calcaneal width	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Radiographic Parameters - Calcaneal Length	Calcaneal length	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - VAS	Assess Visual Analogue pain score(VAS). This will be a patient reported measure from 0-10, minimum score of 0 (no pain), maximum score of 10 (most pain).	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.
Functional Outcomes - FFI-R	Revised foot function index questionnaire (FFI-R) will assess patient pain, stiffness, activity, difficulties with ambulation, and social issues. The score is tabulated from 34 questions answered 1-5 (1= none of the time, 5= All of the time, scale 34-170). Higher scores indicate worse outcomes.	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - FAAM ADL	Foot and Ankle Ability measure activities of daily living (FAAM ADL) is a 21-item activities assessing the patient's functionality related to their activities of daily living. The response to each item is scored from 4 to 0, with 4 being ''no difficulty'' and 0 being ''unable to do." Scale 0-84. Higher scores indicate a more favorable functional level.	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Functional Outcomes - FAAM Sport	Foot and Ankle Ability measure activities of daily living (FAAM Sport) is a 8-item questionnaire assess the patient's ability to participate in athletic activities. The response to each item is scored from 4 to 0, with 4 being ''no difficulty'' and 0 being ''unable to do." Scale 0-32. Higher scores indicate a more favorable functional level.	Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Christopher D Kreulen, MD, MS, Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2019
• Primary Completion (Actual): September 3, 2019
• Study Completion (Actual): September 3, 2019

Study Registration Dates

• First Submitted: August 7, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Splinting; Staged External Fixation; Soft tissue complications
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 1436830

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No