Treatment of Type I Supracondylar Fractures of the Humerus

Type I Supracondylar Fracture of the Humerus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00904137
• Other study ID #: H08-02904
• Status: Terminated
• Phase: N/A
• First received: May 15, 2009
• Last updated: January 8, 2018
• Start date: May 2009
• Est. completion date: January 2014

Study information

• Verified date: January 2018
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Type I Supracondylar Fracture of the Humerus

Intervention

Procedure:
• Cast

• Splint

• Tape

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain intensity and median pain duration over treatment period		3 weeks
Secondary	Amount of analgesia required during treatment period, incidence of complications associated with treatment		3 weeks