Waterproof Casting for Pediatric Distal Radius Fractures

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02095106

Enrollment

Registered

2014-03-24

Start date

2014-04-30

Completion date

2015-10-31

Last updated

2017-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Distal Radius Fractures

Keywords

forearm fractures, pediatric fractures, distal radius

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.

Interventions

DEVICEWaterproof Cast

DEVICETraditional cast

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 14 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Without Fracture Displacement at 8 Weeks Post Injury	8 weeks post injury	The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.

Secondary

Measure	Time frame	Description
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	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.

Other

Measure	Time frame	Description
Itchiness	4 weeks post-injury	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.
Physical Function	4 weeks post-injury	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.
Pain	4 weeks post-injury	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 \[right now\].
Patient Satisfaction	4 weeks post-injury	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).

Countries

United States

Participant flow

Participants by arm

Arm	Count
Traditional Cast First Patients in this group first received a traditional fiberglass cast for two weeks, after which this cast was removed and a waterproof cast applied. Waterproof Cast Traditional cast	14
Waterproof Cast First Patients in this group received a waterproof cast for 2 weeks, after which the waterproof cast was removed and a traditional fiberglass cast applied for an additional two weeks. Waterproof Cast Traditional cast	12
Total	26

Withdrawals & dropouts

Period	Reason	FG000	FG001
Second Intervention (14 Days)	Withdrawal by Subject	0	1

Baseline characteristics

Characteristic	Waterproof Cast First	Traditional Cast First	Total
Age, Categorical <=18 years	12 Participants	14 Participants	26 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	0 Participants	0 Participants	0 Participants
Age, Continuous	10.3 years STANDARD_DEVIATION 1.7	8.6 years STANDARD_DEVIATION 2.3	9.4 years STANDARD_DEVIATION 2.17
Region of Enrollment United States	12 participants	14 participants	26 participants
Sex: Female, Male Female	5 Participants	6 Participants	11 Participants
Sex: Female, Male Male	7 Participants	8 Participants	15 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 26	0 / 27
other Total, other adverse events	0 / 26	0 / 27
serious Total, serious adverse events	0 / 26	0 / 27

Outcome results

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.

Time frame: 8 weeks post injury

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Traditional Cast	Number of Participants Without Fracture Displacement at 8 Weeks Post Injury	26 Participants
Waterproof Cast	Number of Participants Without Fracture Displacement at 8 Weeks Post Injury	27 Participants

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.