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

May 15, 2009
June 20, 2014
May 2009
September 2015   (final data collection date for primary outcome measure)
Mean pain intensity and median pain duration over treatment period [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00904137 on ClinicalTrials.gov Archive Site
Amount of analgesia required during treatment period, incidence of complications associated with treatment [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Type I Supracondylar Fractures of the Humerus
Taping Versus Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type I Supracondylar Fracture of the Humerus
  • Procedure: Cast
  • Procedure: Splint
  • Procedure: Tape
  • Active Comparator: Cast
    Above elbow fiberglass cast with a collar-and-cuff
    Intervention: Procedure: Cast
  • Active Comparator: Splint
    Long arm posterior plaster splint with a collar-and-cuff
    Intervention: Procedure: Splint
  • Active Comparator: Tape
    Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff
    Intervention: Procedure: Tape
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
87
September 2015
September 2015   (final data collection date for primary outcome measure)

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
Both
4 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00904137
H08-02904
No
University of British Columbia
University of British Columbia
Not Provided
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
University of British Columbia
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP