Waterproof Casting for Pediatric Distal Radius Fractures

NCT02095106 | Completed Results

• 1 other identifier: 14-000218
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Distal Radius Fractures

Keywords

forearm fractures; pediatric fractures; distal radius

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

  4 weeks post-injury

Other Outcomes (4)

• Itchiness

  4 weeks post-injury

• Physical Function

  4 weeks post-injury

• Pain

  4 weeks post-injury

Study Arms (2)

Traditional cast first

OTHER

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; Device: Traditional cast

Waterproof cast first

OTHER

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; Device: Traditional cast

Interventions

Waterproof Cast DEVICE

Also known as: HM Cast

Traditional cast first; Waterproof cast first

Traditional cast DEVICE

Also known as: 3M Traditional fiberglass cast

Traditional cast first; Waterproof cast first

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Orthopaedic Institute for Children

Los Angeles, California, 90007, United States

Location

Results Point of Contact

• Title: Dr. Mauricio Silva
• Organization: Orthopaedic Institute for Children

msilva@mednet.ucla.edu

213-742-1109

Study Officials

• Mauricio Silva, MD

  UCLA, Orthopaedic Institute for Children

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Orthopaedic Institute for Children

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: March 24, 2014
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 2, 2017
• Results First Posted: December 2, 2017

Record last verified: 2017-09

Locations

US (1)