Treatment of Type I Supracondylar Fractures of the Humerus

Study Overview
=================
Brief Summary
-----------------
Type I supracondylar fractures are elbow fractures that occur in children aged 3-10 years. Many different treatment options exist to treat this type of fracture. The purpose of this study is to compare three different treatment modalities with regards to pain experienced during treatment, the amount of pain medication needed during treatment, and any short-term complications. We hypothesize that above elbow casting and long-arm splinting will result in less pain and have fewer complications than taping the elbow in flexion.

Detailed Description
-----------------
Patients who meet the inclusion criteria will be enrolled into the study either by the attending physician in the Emergency Department at BC Children's hospital or by one of the study investigators. They will be randomly assigned to one of three treatment groups: above elbow cast, long arm splint, or tape. After being treated, patients will be required to fill in a daily pain diary describing their level of pain and how much analgesia they are requiring. They will also be followed by regular phone calls to track any complications of treatment (e.g. loosening or shifting of cast/ splint/ tape, any skin breakdown, etc.). Patients will be seen for follow-up at three weeks post-injury in the Orthopedics Clinic at BCCH to have radiographs repeated, finish their treatment, and hand in their pain diaries.

Official Title
-----------------
Taping Versus Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial

Conditions
-----------------
Type I Supracondylar Fracture of the Humerus

Intervention / Treatment
-----------------
* Procedure: Cast
* Procedure: Splint
* Procedure: Tape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 4-12 years who present to the Emergency department at BC Children's hospital with a history of elbow trauma, and are diagnosed by the staff emergency physician to have a Type I supracondylar fracture of the humerus (as seen on AP and lateral radiographs of the elbow) Exclusion Criteria: patients with neurovascular compromise associated with the fracture a pre-existing diagnosis of metabolic or structural bone disease that predisposes them to fractures presence of other fractures of the ipsilateral upper extremity

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cast<br>Above elbow fiberglass cast with a collar-and-cuff | Procedure: Cast<br> <br> |
| Active Comparator: Splint<br>Long arm posterior plaster splint with a collar-and-cuff | Procedure: Splint<br> <br> |
| Active Comparator: Tape<br>Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff | Procedure: Tape<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain intensity and median pain duration over treatment period |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of analgesia required during treatment period, incidence of complications associated with treatment |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Supracondylar fracture, elbow, humerus