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Treatment of Type I Supracondylar Fractures of the Humerus

University of British Columbia logo

University of British Columbia

Status

Terminated

Conditions

Type I Supracondylar Fracture of the Humerus

Treatments

Procedure: Cast
Procedure: Splint
Procedure: Tape

Study type

Interventional

Funder types

Other

Identifiers

NCT00904137
H08-02904

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

4 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

12 participants in 3 patient groups

Cast
Active Comparator group
Description:
Above elbow fiberglass cast with a collar-and-cuff
Treatment:
Procedure: Cast
Splint
Active Comparator group
Description:
Long arm posterior plaster splint with a collar-and-cuff
Treatment:
Procedure: Splint
Tape
Active Comparator group
Description:
Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff
Treatment:
Procedure: Tape

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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