Waterproof Casting for Pediatric Distal Radius Fractures
Primary Purpose
Pediatric Distal Radius Fractures
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Waterproof Cast
Traditional cast
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Distal Radius Fractures focused on measuring forearm fractures, pediatric fractures, distal radius
Eligibility Criteria
Inclusion Criteria:
- Patients between 4 and 14 years of age (open physis)
- Patients seen at Orthopedic Institute for Children within 7 days of the original injury
- Patients with a closed, buckle, or minimally displaced and angulated fracture (< 15 degrees of angulation on sagittal or coronal planes) of the distal radius, with or without associated distal ulnar fracture.
Exclusion Criteria:
- Skeletally mature patients (closed physis), or patients younger than 4 or older than 14 years of age.
- Patients with displaced distal radius fractures (at least 15 degrees of angulation on sagittal or coronal planes or bayoneted apposition)
- Any association generalized condition that affects the forearm or wrist range of motion.
- Patients with history of a previous injury or surgery to the contralateral forearm or wrist.
- Patients who received previous treatment for a forearm fracture
- Open fractures
Sites / Locations
- Orthopaedic Institute for Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Traditional cast first
Waterproof cast first
Arm Description
Patients in this group will first receive a traditional fiberglass cast for two weeks, after which this cast will be removed and a waterproof cast applied.
Patients in this group will receive a waterproof cast for 2 weeks, after which the waterproof cast will be removed and a traditional fiberglass cast will be applied for an additional two weeks.
Outcomes
Primary Outcome Measures
Number of Participants Without Fracture Displacement at 8 Weeks Post Injury
The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.
Secondary Outcome Measures
Number of Participants Without Skin Irritation at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type)
Skin changes were assessed after removal of the cast by an independent observer blinded to the type of cast that had been removed, with digital photographs obtained and analyzed using Image J Image Processing and Analysis Software to calculate the surface area of any described skin changes as a percentage of total skin area originally covered by the cast.
Full Information
NCT ID
NCT02095106
First Posted
March 20, 2014
Last Updated
October 26, 2017
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02095106
Brief Title
Waterproof Casting for Pediatric Distal Radius Fractures
Official Title
Waterproof Casting for Pediatric Distal Radius Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Distal radius fractures are one of the most commonly seen fractures in children. Traditionally, minimally angulated or non-displaced distal radius fractures are treated with short or long-arm cast immobilization for up to 8 weeks. The traditional fiberglass casts used must be kept dry to prevent inflammation and potential infection. If a fiberglass cast gets wet, it must be removed and replaced. In general, waterproof casting has been shown to improve patient comfort and overall satisfaction.
We intend to explore the efficacy of a new, waterproof cast made of a hybrid mesh in the treatment of minimally angulated distal radius fractures in children using a randomized, controlled, cross-over study design. We will include patients between 4 and 14 years of age with minimally angulated distal radius fractures (<15 degrees of angulation on sagittal or coronal planes) presented to the Orthopaedic Institute for Children Urgent Care Facility within 7 days of injury. As determined by a power analysis, a total of 26 patients will be enrolled in the study.
Patients eligible for the study will be randomized into one of two equally sized (n=13) groups: patients in Group 1 will receive a short arm cast made of the waterproof hybrid mesh material and patients in Group 2 will receive a regular fiberglass cast. Both groups will follow-up at two weeks for clinical and radiological evaluation, after which they will be transitioned into a regular fiberglass cast (Group 1) or a hybrid mesh waterproof cast (Group 2) for an additional two weeks. This crossover will allow both groups to experience each type of cast. After four weeks of immobilization, patients in both groups will discontinue casting and be advised to avoid contact sports or strenuous activities until week 8.
Patients in both groups will follow up 8 weeks after initial treatment for clinical and radiological evaluation to evaluate range of motion, pain, and fracture alignment. Physical function will be evaluated at weeks 1, 2, and 4 using the Activities Scale for Kids - Performance, a validated, highly reliable, self-reported measure that assesses physical function in children between 5 and 15 years. Pain will be evaluated using the Faces Pain Scale, a validated, highly reliable scale commonly used in the pediatric population. Patient satisfaction will be measured at Weeks 1, 2, and 4, and the radiographs at Week 8 will be compared with initial radiographs to assess fracture displacement and angulation. Skin changes will be assessed at week 2 and week 4 by an independent observer blinded to the type of cast that has been removed and digital photographs will be obtained and analyzed using ImageJ Image Processing and Analysis Software to calculate the surface area of any described skin changes as a percentage of total skin area originally covered by the cast. Itching will be assessed at weeks 1, 2, and 4 using a visual analogue scale in which a horizontal line of 100 mm will be presented to the patient with "no itching" at the left end of the scale and "strongest itching" at the right end.
We hope to determine whether the new, waterproof cast can result in similar clinical outcomes and patient satisfaction for distal radius fractures as compared with the traditional fiberglass cast.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Distal Radius Fractures
Keywords
forearm fractures, pediatric fractures, distal radius
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traditional cast first
Arm Type
Other
Arm Description
Patients in this group will first receive a traditional fiberglass cast for two weeks, after which this cast will be removed and a waterproof cast applied.
Arm Title
Waterproof cast first
Arm Type
Other
Arm Description
Patients in this group will receive a waterproof cast for 2 weeks, after which the waterproof cast will be removed and a traditional fiberglass cast will be applied for an additional two weeks.
Intervention Type
Device
Intervention Name(s)
Waterproof Cast
Other Intervention Name(s)
HM Cast
Intervention Type
Device
Intervention Name(s)
Traditional cast
Other Intervention Name(s)
3M Traditional fiberglass cast
Primary Outcome Measure Information:
Title
Number of Participants Without Fracture Displacement at 8 Weeks Post Injury
Description
The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.
Time Frame
8 weeks post injury
Secondary Outcome Measure Information:
Title
Number of Participants Without Skin Irritation at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type)
Description
Skin changes were assessed after removal of the cast by an independent observer blinded to the type of cast that had been removed, with digital photographs obtained and analyzed using Image J Image Processing and Analysis Software to calculate the surface area of any described skin changes as a percentage of total skin area originally covered by the cast.
Time Frame
4 weeks post-injury
Other Pre-specified Outcome Measures:
Title
Itchiness
Description
Itchiness was assessed using a visual analog scale at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type). This scale consisted of a horizontal line of 100 mm presented to the patient, with the term "no itching" at the left end of the scale and the term "strong itching" appearing at the right end of the scale.
Time Frame
4 weeks post-injury
Title
Physical Function
Description
Physical function was evaluated using the Activities Scale for Kids - Performance (ASKp) at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) - to ensure that the measurement represented only the time in which the participant received each type of intervention. The ASKp is a validated, highly reliable, self-reported measure that assesses physical function in children between 5 and 15 years. Scale ranges from 0 to 100 with higher scores representing more physical activity.
Time Frame
4 weeks post-injury
Title
Pain
Description
Pain was evaluated at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) using the Faces Pain Scale, a validated, highly reliable scale commonly used in the pediatric population. The Faces Pain Scale is a numerical self-report measure of pain intensity developed for children to score the sensation of pain from 0-10. Pictures of 6 cartoon faces ranging from neutral expression of "no pain" (0) to "very much pain" (10). Participant is asked to point to the face that shows how much participant hurts at the time of assessment [right now].
Time Frame
4 weeks post-injury
Title
Patient Satisfaction
Description
Patient satisfaction with the treatment was measured at the Time of Cast Removal (2 Weeks From Injury for First Intervention Type) and at Final Cast Removal (4 Weeks Post Injury for Second Intervention Type) with a survey that was presented to the patient or parent, asking them to rate the satisfaction on a scale from 1 (less satisfied) to 100 (more satisfied).
Time Frame
4 weeks post-injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients between 4 and 14 years of age (open physis)
Patients seen at Orthopedic Institute for Children within 7 days of the original injury
Patients with a closed, buckle, or minimally displaced and angulated fracture (< 15 degrees of angulation on sagittal or coronal planes) of the distal radius, with or without associated distal ulnar fracture.
Exclusion Criteria:
Skeletally mature patients (closed physis), or patients younger than 4 or older than 14 years of age.
Patients with displaced distal radius fractures (at least 15 degrees of angulation on sagittal or coronal planes or bayoneted apposition)
Any association generalized condition that affects the forearm or wrist range of motion.
Patients with history of a previous injury or surgery to the contralateral forearm or wrist.
Patients who received previous treatment for a forearm fracture
Open fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauricio Silva, MD
Organizational Affiliation
UCLA, Orthopaedic Institute for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic Institute for Children
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Waterproof Casting for Pediatric Distal Radius Fractures
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