Clinical trial NCT00904137: Treatment of Type I Supracondylar Fractures of the Humerus
Official title: Taping Versus Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type I Supracondylar Fracture of the Humerus
Keywords: Supracondylar fracture
humerus
elbow
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2009-05-19
Enrollment: 12
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean pain intensity and median pain duration over treatment period
timeFrame: 3 weeks
Secondary outcomes:
measure: Amount of analgesia required during treatment period, incidence of complications associated with treatment
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Kishore Mulpuri
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Renjit Varghese
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Lisa Dyke
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Firoz Miyanji
role: STUDY_DIRECTOR
affiliation: University of British Columbia
name: Christopher Reilly
role: STUDY_DIRECTOR
References: