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External Fixation Versus Splinting of Acute Calcaneus Fractures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04063657
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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

Condition or disease Intervention/treatment Phase
Calcaneus Fracture Procedure: External fixator Procedure: Splinting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: External Fixation Versus Splinting of Acute Calcaneus Fractures Prior to Definitive Surgery
Actual Study Start Date : June 14, 2019
Estimated Primary Completion Date : August 29, 2021
Estimated Study Completion Date : August 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

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.




Primary Outcome Measures :
  1. Time to definitive surgery [ Time Frame: Within 2 weeks from injury ]
    Duration of time from injury to definitive surgery

  2. Soft tissue complications [ Time Frame: Assessed at 2 weeks after surgery ]
    Incidence of infection, dehiscence and need for soft tissue coverage

  3. Soft tissue complications [ Time Frame: Assessed at 6 weeks after surgery ]
    Incidence of infection, dehiscence and need for soft tissue coverage

  4. Soft tissue complications [ Time Frame: Assessed at 12 weeks after surgery ]
    Incidence of infection, dehiscence and need for soft tissue coverage

  5. Soft tissue complications [ Time Frame: Assessed at 6 months after surgery ]
    Incidence of infection, dehiscence and need for soft tissue coverage

  6. Soft tissue complications [ Time Frame: Assessed at 12 months after surgery ]
    Incidence of infection, dehiscence and need for soft tissue coverage

  7. Soft tissue complications [ Time Frame: Assessed at 24 months after surgery ]
    Incidence of infection, dehiscence and need for soft tissue coverage


Secondary Outcome Measures :
  1. Union rate [ Time Frame: Plain xrays at 6 weeks, 12 weeks, 6 months, 1 year, and 2 years after surgery. CT scan at 1 year. ]
    Assessment of fracture healing

  2. Radiographic parameters - Bohler's angle [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery ]
    Bohler's angle

  3. Radiographic parameters - Calcaneal height [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery ]
    Calcaneal height

  4. Radiographic parameters - Angle of Gissan [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery ]
    Angle of Gissan

  5. Radiographic parameters - Calcaneal width [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery ]
    Calcaneal width

  6. Radiographic parameters - Calcaneal length [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery ]
    Calcaneal length

  7. Functional outcomes - VAS [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery. ]
    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).

  8. Functional outcomes - FFI-R [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery ]
    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.

  9. Functional outcomes - FAAM ADL [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery ]
    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.

  10. Functional outcomes - FAAM Sport [ Time Frame: Assessed at 2, 6, & 12 weeks, and 6, 12, & 24 months after surgery ]
    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.



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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04063657


Contacts
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Contact: Max R Haffner, MD (916) 734-5885 mrhaffner@ucdavis.edu
Contact: Augustine M Saiz Jr., MD (916) 734-5885 amsaiz@ucdavis.edu

Locations
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United States, California
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Max R Haffner, MD    916-734-5885    mrhaffner@ucdavis.edu   
Contact: Augustine M Saiz Jr, MD    (916) 734-5885    amsaiz@ucdavis.edu   
Principal Investigator: Christopher D Kreulen, MD,MS         
Sponsors and Collaborators
University of California, Davis
Investigators
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Principal Investigator: Christopher D Kreulen, MD, MS Foot and Ankle Surgery Department of Orthopaedic Surgery University of California, Davis Medical Center
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT04063657    
Other Study ID Numbers: 1436830
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, Davis:
Staged External Fixation
Splinting
Soft tissue complications
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries