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External Fixation Versus Splinting of Acute Calcaneus Fractures

Primary Purpose

Calcaneus Fracture

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
External fixator
Splinting
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcaneus Fracture focused on measuring Staged External Fixation, Splinting, Soft tissue complications

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of California, Davis Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

External fixation

Splinting

Arm 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.

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.

Outcomes

Primary Outcome Measures

Time to Definitive Surgery
Duration of time from injury to definitive surgery
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage
Soft Tissue Complications
Incidence of infection, dehiscence and need for soft tissue coverage

Secondary Outcome Measures

Union Rate
Assessment of fracture healing
Radiographic Parameters - Bohler's Angle
Bohler's angle
Radiographic Parameters - Calcaneal Height
Calcaneal height
Radiographic Parameters - Angle of Gissan
Angle of Gissan
Radiographic Parameters - Calcaneal Width
Calcaneal width
Radiographic Parameters - Calcaneal Length
Calcaneal length
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).
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.
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.
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.

Full Information

First Posted
August 7, 2019
Last Updated
January 12, 2022
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04063657
Brief Title
External Fixation Versus Splinting of Acute Calcaneus Fractures
Official Title
External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was slow to recruit. PI decided to close study to focus on other trials.
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
September 3, 2019 (Actual)
Study Completion Date
September 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

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

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcaneus Fracture
Keywords
Staged External Fixation, Splinting, Soft tissue complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External fixation
Arm Type
Active Comparator
Arm 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.
Arm Title
Splinting
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
External fixator
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Splinting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to Definitive Surgery
Description
Duration of time from injury to definitive surgery
Time Frame
Within 2 weeks from injury
Title
Soft Tissue Complications
Description
Incidence of infection, dehiscence and need for soft tissue coverage
Time Frame
Assessed at 2 weeks after surgery
Title
Soft Tissue Complications
Description
Incidence of infection, dehiscence and need for soft tissue coverage
Time Frame
Assessed at 6 weeks after surgery
Title
Soft Tissue Complications
Description
Incidence of infection, dehiscence and need for soft tissue coverage
Time Frame
Assessed at 12 weeks after surgery
Title
Soft Tissue Complications
Description
Incidence of infection, dehiscence and need for soft tissue coverage
Time Frame
Assessed at 6 months after surgery
Title
Soft Tissue Complications
Description
Incidence of infection, dehiscence and need for soft tissue coverage
Time Frame
Assessed at 12 months after surgery
Title
Soft Tissue Complications
Description
Incidence of infection, dehiscence and need for soft tissue coverage
Time Frame
Assessed at 24 months after surgery
Secondary Outcome Measure Information:
Title
Union Rate
Description
Assessment of fracture healing
Time Frame
Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year.
Title
Radiographic Parameters - Bohler's Angle
Description
Bohler's angle
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Title
Radiographic Parameters - Calcaneal Height
Description
Calcaneal height
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Title
Radiographic Parameters - Angle of Gissan
Description
Angle of Gissan
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Title
Radiographic Parameters - Calcaneal Width
Description
Calcaneal width
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Title
Radiographic Parameters - Calcaneal Length
Description
Calcaneal length
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Title
Functional Outcomes - VAS
Description
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).
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery.
Title
Functional Outcomes - FFI-R
Description
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.
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Title
Functional Outcomes - FAAM ADL
Description
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.
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery
Title
Functional Outcomes - FAAM Sport
Description
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.
Time Frame
Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher D Kreulen, MD, MS
Organizational Affiliation
Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

External Fixation Versus Splinting of Acute Calcaneus Fractures

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