Pediatric Distal Radius Fractures Clinical Trial
Official title:
Waterproof Casting for Pediatric Distal Radius Fractures
| Verified date | September 2017 |
| Source | University of California, Los Angeles |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 4 Years to 14 Years |
| Eligibility |
Inclusion Criteria: 1. Patients between 4 and 14 years of age (open physis) 2. Patients seen at Orthopedic Institute for Children within 7 days of the original injury 3. 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: 1. Skeletally mature patients (closed physis), or patients younger than 4 or older than 14 years of age. 2. Patients with displaced distal radius fractures (at least 15 degrees of angulation on sagittal or coronal planes or bayoneted apposition) 3. Any association generalized condition that affects the forearm or wrist range of motion. 4. Patients with history of a previous injury or surgery to the contralateral forearm or wrist. 5. Patients who received previous treatment for a forearm fracture 6. Open fractures |
| Country | Name | City | State |
|---|---|---|---|
| United States | Orthopaedic Institute for Children | Los Angeles | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Los Angeles |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Itchiness | 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. | 4 weeks post-injury | |
| Other | Physical Function | 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. | 4 weeks post-injury | |
| Other | Pain | 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]. | 4 weeks post-injury | |
| Other | Patient Satisfaction | 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). | 4 weeks post-injury | |
| Primary | 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. | 8 weeks post injury | |
| Secondary | 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. | 4 weeks post-injury |