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Treatment of Type I Supracondylar Fractures of the Humerus

This study has suspended participant recruitment.
(Protocol modification is in progress due to low enrollment)
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00904137
First received: May 15, 2009
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Type I Supracondylar Fracture of the Humerus
Procedure: Cast
Procedure: Splint
Procedure: Tape

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Taping Versus Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Mean pain intensity and median pain duration over treatment period [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Amount of analgesia required during treatment period, incidence of complications associated with treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 87
Study Start Date: May 2009
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cast
Above elbow fiberglass cast with a collar-and-cuff
Procedure: Cast
Active Comparator: Splint
Long arm posterior plaster splint with a collar-and-cuff
Procedure: Splint
Active Comparator: Tape
Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff
Procedure: Tape

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

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00904137

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Kishore Mulpuri University of British Columbia
Study Director: Renjit Varghese University of British Columbia
Study Director: Lisa Dyke University of British Columbia
Study Director: Firoz Miyanji University of British Columbia
Study Director: Christopher Reilly University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00904137     History of Changes
Other Study ID Numbers: H08-02904
Study First Received: May 15, 2009
Last Updated: June 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Supracondylar fracture
humerus
elbow

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014