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

Humeral Fractures Clinical Trial

Official title: Telemedicine in Supracondylar Humerus Fractures

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures

• NCT number: NCT02640027
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Completion date: June 2017