Study Stopped
We were unable to recruit the appropriate numbers as parents did not want to randomize their child for the treatments options.
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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 15, 2009
CompletedFirst Posted
Study publicly available on registry
May 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedJanuary 10, 2018
January 1, 2018
4.7 years
May 15, 2009
January 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean pain intensity and median pain duration over treatment period
3 weeks
Secondary Outcomes (1)
Amount of analgesia required during treatment period, incidence of complications associated with treatment
3 weeks
Study Arms (3)
Cast
ACTIVE COMPARATORAbove elbow fiberglass cast with a collar-and-cuff
Splint
ACTIVE COMPARATORLong arm posterior plaster splint with a collar-and-cuff
Tape
ACTIVE COMPARATORElastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Children's Hospital
Vancouver, British Columbia, V6H 3V4, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 15, 2009
First Posted
May 19, 2009
Study Start
May 1, 2009
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
January 10, 2018
Record last verified: 2018-01