Trial Outcomes & Findings for Waterproof Casting for Pediatric Distal Radius Fractures (NCT NCT02095106)

NCT ID: NCT02095106

Last Updated: 2017-12-02

Results Overview

The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 8 weeks post injury
• Results posted on: 2017-12-02

Participant Flow

Participant milestones

Measure	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	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
First Intervention (14 Days) STARTED	14	13
First Intervention (14 Days) COMPLETED	14	13
First Intervention (14 Days) NOT COMPLETED	0	0
Second Intervention (14 Days) STARTED	14	13
Second Intervention (14 Days) COMPLETED	14	12
Second Intervention (14 Days) NOT COMPLETED	0	1

Reasons for withdrawal

Measure	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	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
Second Intervention (14 Days) Withdrawal by Subject	0	1

Baseline Characteristics

Waterproof Casting for Pediatric Distal Radius Fractures

Baseline characteristics by cohort

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

PRIMARY outcome

Timeframe: 8 weeks post injury

The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.

Outcome measures

Measure	Traditional Cast n=26 Participants Patients in this group were assessed after wearing the traditional cast for 2 weeks, as their first or second intervention.	Waterproof Cast n=27 Participants Patients in this group were assessed after wearing a waterproof cast for 2 weeks, as the first or second intervention type.
Number of Participants Without Fracture Displacement at 8 Weeks Post Injury	26 Participants	27 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Traditional Cast n=26 Participants Patients in this group were assessed after wearing the traditional cast for 2 weeks, as their first or second intervention.	Waterproof Cast n=27 Participants Patients in this group were assessed after wearing a waterproof cast for 2 weeks, as the first or second intervention type.
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)	26 Participants	27 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Traditional Cast n=26 Participants Patients in this group were assessed after wearing the traditional cast for 2 weeks, as their first or second intervention.	Waterproof Cast n=27 Participants Patients in this group were assessed after wearing a waterproof cast for 2 weeks, as the first or second intervention type.
Itchiness	3.58 units on a scale Interval 0.0 to 10.0	3.2 units on a scale Interval 0.0 to 8.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Traditional Cast n=26 Participants Patients in this group were assessed after wearing the traditional cast for 2 weeks, as their first or second intervention.	Waterproof Cast n=27 Participants Patients in this group were assessed after wearing a waterproof cast for 2 weeks, as the first or second intervention type.
Physical Function	78.06 units on a scale Interval 31.9 to 99.2	85.74 units on a scale Interval 49.2 to 100.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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].

Outcome measures

Measure	Traditional Cast n=26 Participants Patients in this group were assessed after wearing the traditional cast for 2 weeks, as their first or second intervention.	Waterproof Cast n=27 Participants Patients in this group were assessed after wearing a waterproof cast for 2 weeks, as the first or second intervention type.
Pain	0.8 score Interval 0.0 to 3.0	0.6 score Interval 0.0 to 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 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).

Outcome measures

Measure	Traditional Cast n=26 Participants Patients in this group were assessed after wearing the traditional cast for 2 weeks, as their first or second intervention.	Waterproof Cast n=27 Participants Patients in this group were assessed after wearing a waterproof cast for 2 weeks, as the first or second intervention type.
Patient Satisfaction	83.9 units on a scale Interval 60.6 to 100.0	84.0 units on a scale Interval 22.5 to 100.0

Adverse Events

Traditional Cast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waterproof Cast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mauricio Silva

Orthopaedic Institute for Children

Phone: 213-742-1109

Email: msilva@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place