Randomized Trial of Casting Techniques for Displaced Forearm Fractures
Primary Purpose
Displaced Forearm Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bivalved cast
Circumferential cast
Sponsored by
About this trial
This is an interventional treatment trial for Displaced Forearm Fractures focused on measuring Casting techniques, Bivalved cast, Circumferential cast, Displaced distal radius fracture, Children
Eligibility Criteria
Inclusion Criteria:
- Displaced distal radius or mid-diaphyseal forearm fracture
- fracture requires closed reduction and cast immobilization
- Age 4-16 years
- Skeletally immature
Exclusion Criteria:
- Failed closed reduction
- Acute fracture > 1 week old
- Refracture injury
- Fracture requires surgical treatment
- Significant soft tissue swelling
- Associated neurovascular compromise
- Plastic deformation injuries
Sites / Locations
- Childrens Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bivalved cast
Circumferential cast
Arm Description
Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
Outcomes
Primary Outcome Measures
Loss of Radius Fracture Reduction
The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.
Secondary Outcome Measures
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations
The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.
Full Information
NCT ID
NCT00823823
First Posted
January 15, 2009
Last Updated
September 2, 2014
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00823823
Brief Title
Randomized Trial of Casting Techniques for Displaced Forearm Fractures
Official Title
Randomized Trial of Bivalved and Circumferential Casting for Displaced Forearm Fractures in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
It is recognized that fractures of the distal radius and forearm occur in approximately one in 100 children and adolescents every year. Though closed manipulation and cast immobilization of displaced injuries is the mainstay of treatment in the majority of cases, the optimal type of cast remains debatable. Though well-molded casts theoretically provide the best ability to maintain fracture alignment, risks of circumferential immobilization in acute injuries include neurovascular compromise. Splitting, or bivalving, casts may reduce these risks, but the effect on fracture stability is unknown. The proposed investigation seeks to address the simple question of whether circumferential or bivalved casts provide the best outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Displaced Forearm Fractures
Keywords
Casting techniques, Bivalved cast, Circumferential cast, Displaced distal radius fracture, Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bivalved cast
Arm Type
Active Comparator
Arm Description
Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
Arm Title
Circumferential cast
Arm Type
Active Comparator
Arm Description
Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
Intervention Type
Other
Intervention Name(s)
Bivalved cast
Intervention Description
Circumferential cast will be applied following closed reduction and then bivalved using a cast saw
Intervention Type
Other
Intervention Name(s)
Circumferential cast
Intervention Description
Circumferential cast will be applied following closed reduction
Primary Outcome Measure Information:
Title
Loss of Radius Fracture Reduction
Description
The number of participants that experienced radiographic loss of reduction by four weeks post-randomization.
Time Frame
4 weeks post-randomization
Secondary Outcome Measure Information:
Title
Compartment Syndrome or Neurovascular Compromise, Saw Burns and/or Lacerations
Description
The number of participants that experienced compartment syndrome or neurovascular compromise, saw burn and/or laceration within four weeks post-randomization.
Time Frame
Up to 4 weeks post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Displaced distal radius or mid-diaphyseal forearm fracture
fracture requires closed reduction and cast immobilization
Age 4-16 years
Skeletally immature
Exclusion Criteria:
Failed closed reduction
Acute fracture > 1 week old
Refracture injury
Fracture requires surgical treatment
Significant soft tissue swelling
Associated neurovascular compromise
Plastic deformation injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Bae, MD
Organizational Affiliation
Childrens Hospital Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Childrens Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02125
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Randomized Trial of Casting Techniques for Displaced Forearm Fractures
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