Treatment of Type I Supracondylar Fractures of the Humerus

Not Applicable

Terminated

• Conditions: Type I Supracondylar Fracture of the Humerus
• Interventions: Procedure: Tape; Procedure: Cast; Procedure: Splint

• Registration Number: NCT00904137
• Lead Sponsor: University of British Columbia

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.

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-19
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-08
• Last Update Posted: 2018-01-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tape	Tape	Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff
Cast	Cast	Above elbow fiberglass cast with a collar-and-cuff
Splint	Splint	Long arm posterior plaster splint with a collar-and-cuff

Primary Outcome Measures

Name	Time	Method
Mean pain intensity and median pain duration over treatment period	3 weeks

Secondary Outcome Measures

Name	Time	Method
Amount of analgesia required during treatment period, incidence of complications associated with treatment	3 weeks

Trial Locations

Locations (1)

BC Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada