Waterproof Casting for Pediatric Distal Radius Fractures

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Distal Radius Fractures
• Intervention / Treatment: Device: Waterproof Cast; Device: Traditional cast

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90007
      • Orthopaedic Institute for Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Traditional cast first; 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.	Device: Waterproof Cast; Other Names: HM Cast; Device: Traditional cast; Other Names: 3M Traditional fiberglass cast
Other: Waterproof cast first; 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.	Device: Waterproof Cast; Other Names: HM Cast; Device: Traditional cast; Other Names: 3M Traditional fiberglass cast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Investigators: Principal Investigator: Mauricio Silva, MD, UCLA, Orthopaedic Institute for Children

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 20, 2014
• First Submitted That Met QC Criteria: March 20, 2014
• First Posted (Estimate): March 24, 2014

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: forearm fractures; pediatric fractures; distal radius
• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Forearm Injuries; Fractures, Bone; Radius Fractures; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Cysteine Proteinase Inhibitors; Calpastatin
• Other Study ID Numbers: 14-000218