Treatment of Type I Supracondylar Fractures of the Humerus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type I Supracondylar Fracture of the Humerus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cast

Above elbow fiberglass cast with a collar-and-cuff

Group Type ACTIVE_COMPARATOR

Cast

Intervention Type PROCEDURE

Splint

Long arm posterior plaster splint with a collar-and-cuff

Group Type ACTIVE_COMPARATOR

Splint

Intervention Type PROCEDURE

Tape

Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff

Group Type ACTIVE_COMPARATOR

Tape

Intervention Type PROCEDURE

Interventions

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Cast

Intervention Type PROCEDURE

Splint

Intervention Type PROCEDURE

Tape

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes