The Use of Telemedicine Tool in Supracondylar Humerus Fractures in Children

NCT02640027 | Completed

• 1 other identifier: 003
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Humeral Fractures

Outcome Measures

Primary Outcomes (2)

• 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.

  At 8 week follow up visit

• 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.

  At 8 week follow up visit

Secondary Outcomes (2)

• Recovery of Range of Motion Using a 6" E-Z Read Jamar® Goniometer

  8 Weeks after injury

• Elbow Pain Using the Revised Faces Pain Scale

  Weeks 4 and 8 after injury

Study Arms (2)

Treatment in the Clinic Only

NO INTERVENTION

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

Treatment in the Clinic and at Home

EXPERIMENTAL

Cast removal at home using a telemedicine tool

Procedure: Cast removal at home using a telemedicine tool

Interventions

Cast removal at home using a telemedicine tool PROCEDURE

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.

Treatment in the Clinic and at Home

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Conditions

Humeral Fractures

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Orthopaedics

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 28, 2015
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: May 16, 2019

Record last verified: 2019-05