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The Use of Telemedicine Tool in Supracondylar Humerus Fractures in Children (T-SCHF)

Primary Purpose

Humeral Fractures

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cast removal at home using a telemedicine tool
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fractures

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between the ages of 2 and 10 years (open physis), who present within seven days of sustaining a closed, non-displaced, type I supracondylar humeral fracture or a closed, acute elbow injury in whom a fracture is not seen but a positive posterior fat pad sign is identified will be considered for inclusion in the present study. In order to be included, the patient's family must have access to an electronic device with a camera (desktop computer, laptop, tablet or cell phone) with internet connectivity, and be willing to download and use a free application for live videoconferencing (WebEx, Cisco Systems). WebEx is a HIPPA compliant videoconferencing system that includes audio and visual components.

Exclusion Criteria:

  • Patients younger than 2 or older than 10 years of age will be excluded, as well as those with a displaced or open elbow fracture, any associated generalized condition that affects the elbow range of motion, history of a previous injury or surgery to the elbows, a neurovascular abnormalities or suspicion of a compartment syndrome or a pathological fracture.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Treatment in the Clinic Only

    Treatment in the Clinic and at Home

    Arm Description

    Patients in Group A will receive their follow-up care entirely at the investigators institution

    Cast removal at home using a telemedicine tool

    Outcomes

    Primary Outcome Measures

    Fracture displacement as measured by Baumann Angle
    Fracture displacement will be assessed by comparing the initial values of the Baumann angle of the elbow, taken at the 1 week follow up visit, with those obtained during the 8th week follow-up appointment.
    Fracture angulation as measured by Shaft Condylar Angle
    Fracture angulation will be assessed by comparing the initial values of the shaft-condylar angle of the elbow, taken at the 1 week follow up appointment, and the position of the anterior humeral line with respect to the capitellum, with those obtained during the 8th week follow-up appointment.

    Secondary Outcome Measures

    Recovery of Range of Motion Using a 6" E-Z Read Jamar® Goniometer
    The recovery of ROM will be assessed at the 8th week follow-up by comparing the range of motion of the affected elbow with that of the normal, contralateral elbow. The range of motion of the elbow will be measured with the use of a small goniometer calibrated in 1° increments, using standard techniques. All ROM measurements will be performed by a single observer using the same goniometer.
    Elbow Pain Using the Revised Faces Pain Scale
    Elbow pain will be measured at weeks 4 and 8 with the use of the Faces Pain Scale. This is a validated, highly reliable scale, commonly used in the pediatric population. Hicks CL, von Baeyer CL, Spafford PA, et al. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001;93:173-183.

    Full Information

    First Posted
    December 16, 2015
    Last Updated
    May 14, 2019
    Sponsor
    University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02640027
    Brief Title
    The Use of Telemedicine Tool in Supracondylar Humerus Fractures in Children
    Acronym
    T-SCHF
    Official Title
    Telemedicine in Supracondylar Humerus Fractures
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2016 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    June 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Fractures of the supracondylar region of the humerus are among the most common pediatric injuries requiring the attention of an orthopaedic surgeon. Children with non-displaced fractures (Type I), as well as those with history of elbow trauma, have been traditionally managed with non-surgical immobilization. Recently published clinical guidelines support such practice, based on the result of two prospective studies in which either collar and cuff or posterior splint immobilization were used. When compared to collar and cuff immobilization, posterior splints resulted in better pain relief within the first two weeks of injury; however, critical outcomes, including the incidence of cubitus varus, hyperextension, and loss of reduction, were not reported. While posterior splints appear to be an attractive option for the treatment of non-displaced pediatric elbow fractures, a recent retrospective analysis on the use of posterior splints for the treatment of such injuries reported a small proportion of fractures demonstrating displacement. The potential for non-compliance with the use of removable devices, especially in the older pediatric population, is also a concern. The use of a removable immobilization that can reliably maintain fracture alignment, minimize the risk of non-compliance, and result in similar outcomes as those obtained with regular casting could be advantageous: It appears that such immobilization could be removed easily and safely at home, potentially resulting in a lower number of patient visits, decreased health-care costs, and higher patient/parent satisfaction. Telemedicine, defined as the use of telecommunication and information technologies in order to provide clinical health care at a distance, has been seldom used in the field of pediatric orthopaedics. Commonly mentioned attributes of telemedicine include improved access to healthcare providers, cost containment and increased healthcare efficiency, quality care improvements related to patient satisfaction, and potential reduction in travel time for patients and families. The purpose of this randomized, controlled, prospective study is to assess telemedicine as a tool for the treatment follow-up of non-displaced SCHF fractures in children. Investigators hypothesize that using telemedicine will result in comparable clinical outcomes as those obtained in patients treated in a clinical facility, with increased patient satisfaction and decreased healthcare costs.
    Detailed Description
    The investigators will conduct an IRB approved, single-center, randomized, open label trial, in which children who present to the investigators institution with a non-displaced (Type 1) SCHF or an occult elbow injury (as determined by the presence of a posterior fat pad sign) will receive a long-arm soft, fiberglass cast (reinforced with a posterior slab) (3MTD "ScotchcastTM" Soft Cast Casting Tape) with the elbow flexed to 90-100 degrees and with forearm in neutral rotation and will be randomized to one of two groups: Patients in Group A will receive their follow-up care entirely at the investigators institution, while patients in Group B will receive some of the follow-up care using a telemedicine tool. Written informed consent will be obtained from the parents of each patient. For patients between the ages of seven and ten years, child assents will also be obtained. Randomization will be accomplished by using sealed envelopes, sequentially numbered on the outside, in which a random sequence of A or B will be concealed. Sample size estimation was based on the outcome variable of percent average total satisfaction score. The investigators own previous studies at OIC presented a standard deviation of the satisfaction score of 15%. Clinically significant differences in satisfaction scores were on the order of 10 to 15%. In the present study, 25 patients in each group will be included, for a total of 50 patients. With this sample size, the investigators will be able to detect differences of 12% in satisfaction score with alpha of 0.05 and 80% power.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Humeral Fractures

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment in the Clinic Only
    Arm Type
    No Intervention
    Arm Description
    Patients in Group A will receive their follow-up care entirely at the investigators institution
    Arm Title
    Treatment in the Clinic and at Home
    Arm Type
    Experimental
    Arm Description
    Cast removal at home using a telemedicine tool
    Intervention Type
    Procedure
    Intervention Name(s)
    Cast removal at home using a telemedicine tool
    Intervention Description
    Instead of receiving follow up treatment in a clinical setting, patients randomized to the arm of the study requiring telemedicine will receive some of their follow up care at home.
    Primary Outcome Measure Information:
    Title
    Fracture displacement as measured by Baumann Angle
    Description
    Fracture displacement will be assessed by comparing the initial values of the Baumann angle of the elbow, taken at the 1 week follow up visit, with those obtained during the 8th week follow-up appointment.
    Time Frame
    At 8 week follow up visit
    Title
    Fracture angulation as measured by Shaft Condylar Angle
    Description
    Fracture angulation will be assessed by comparing the initial values of the shaft-condylar angle of the elbow, taken at the 1 week follow up appointment, and the position of the anterior humeral line with respect to the capitellum, with those obtained during the 8th week follow-up appointment.
    Time Frame
    At 8 week follow up visit
    Secondary Outcome Measure Information:
    Title
    Recovery of Range of Motion Using a 6" E-Z Read Jamar® Goniometer
    Description
    The recovery of ROM will be assessed at the 8th week follow-up by comparing the range of motion of the affected elbow with that of the normal, contralateral elbow. The range of motion of the elbow will be measured with the use of a small goniometer calibrated in 1° increments, using standard techniques. All ROM measurements will be performed by a single observer using the same goniometer.
    Time Frame
    8 Weeks after injury
    Title
    Elbow Pain Using the Revised Faces Pain Scale
    Description
    Elbow pain will be measured at weeks 4 and 8 with the use of the Faces Pain Scale. This is a validated, highly reliable scale, commonly used in the pediatric population. Hicks CL, von Baeyer CL, Spafford PA, et al. The Faces Pain Scale-Revised: toward a common metric in pediatric pain measurement. Pain. 2001;93:173-183.
    Time Frame
    Weeks 4 and 8 after injury

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients between the ages of 2 and 10 years (open physis), who present within seven days of sustaining a closed, non-displaced, type I supracondylar humeral fracture or a closed, acute elbow injury in whom a fracture is not seen but a positive posterior fat pad sign is identified will be considered for inclusion in the present study. In order to be included, the patient's family must have access to an electronic device with a camera (desktop computer, laptop, tablet or cell phone) with internet connectivity, and be willing to download and use a free application for live videoconferencing (WebEx, Cisco Systems). WebEx is a HIPPA compliant videoconferencing system that includes audio and visual components. Exclusion Criteria: Patients younger than 2 or older than 10 years of age will be excluded, as well as those with a displaced or open elbow fracture, any associated generalized condition that affects the elbow range of motion, history of a previous injury or surgery to the elbows, a neurovascular abnormalities or suspicion of a compartment syndrome or a pathological fracture.

    12. IPD Sharing Statement

    Learn more about this trial

    The Use of Telemedicine Tool in Supracondylar Humerus Fractures in Children

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