Treatment of Type I Supracondylar Fractures of the Humerus
Primary Purpose
Type I Supracondylar Fracture of the Humerus
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cast
Splint
Tape
Sponsored by
About this trial
This is an interventional treatment trial for Type I Supracondylar Fracture of the Humerus focused on measuring Supracondylar fracture, humerus, elbow
Eligibility 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
Sites / Locations
- BC Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Cast
Splint
Tape
Arm Description
Above elbow fiberglass cast with a collar-and-cuff
Long arm posterior plaster splint with a collar-and-cuff
Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff
Outcomes
Primary Outcome Measures
Mean pain intensity and median pain duration over treatment period
Secondary Outcome Measures
Amount of analgesia required during treatment period, incidence of complications associated with treatment
Full Information
NCT ID
NCT00904137
First Posted
May 15, 2009
Last Updated
January 8, 2018
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00904137
Brief Title
Treatment of Type I Supracondylar Fractures of the Humerus
Official Title
Taping Versus Splinting Versus Above Elbow Casting for Type I Supracondylar Fractures of the Humerus in Children: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Terminated
Why Stopped
We were unable to recruit the appropriate numbers as parents did not want to randomize their child for the treatments options.
Study Start Date
May 2009 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type I Supracondylar Fracture of the Humerus
Keywords
Supracondylar fracture, humerus, elbow
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cast
Arm Type
Active Comparator
Arm Description
Above elbow fiberglass cast with a collar-and-cuff
Arm Title
Splint
Arm Type
Active Comparator
Arm Description
Long arm posterior plaster splint with a collar-and-cuff
Arm Title
Tape
Arm Type
Active Comparator
Arm Description
Elastoplast tape applied to keep the elbow in flexion, with a collar-and-cuff
Intervention Type
Procedure
Intervention Name(s)
Cast
Intervention Type
Procedure
Intervention Name(s)
Splint
Intervention Type
Procedure
Intervention Name(s)
Tape
Primary Outcome Measure Information:
Title
Mean pain intensity and median pain duration over treatment period
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Amount of analgesia required during treatment period, incidence of complications associated with treatment
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishore Mulpuri
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renjit Varghese
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lisa Dyke
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Firoz Miyanji
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Christopher Reilly
Organizational Affiliation
University of British Columbia
Official's Role
Study Director
Facility Information:
Facility Name
BC Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Treatment of Type I Supracondylar Fractures of the Humerus
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