The Use of Telemedicine Tool in Supracondylar Humerus Fractures in Children
Condition: Humeral Fractures
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Interventional

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.
    

Intervention name(s): Cast removal at home using a telemedicine tool
Intervention type(s): Procedure
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment