Pediatric Distal Radius FracturesNCT02095106
Waterproof Casting for Pediatric Distal Radius Fractures
A study testing Waterproof Cast and Traditional cast in people with Pediatric Distal Radius Fractures, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Pediatric Distal Radius Fractures
- What is being tested?
- Waterproof Cast and Traditional cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Orthopaedic Institute for Children
Los Angeles, California, 90007
About this study
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.
Read more
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
- Being tested
- Waterproof Cast, Traditional cast
- Keywords
- forearm fractures, pediatric fractures, distal radius
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Waterproof CastDevice
Also called HM Cast
Traditional castDevice
Also called 3M Traditional fiberglass cast
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Waterproof Cast; Device: Traditional cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 4 weeks post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric Distal Radius FracturesStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauricio Silva, University of California, Los Angeles
- Investigators
- Mauricio Silva, MD, Principal investigator, UCLA, Orthopaedic Institute for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095106
- Sponsor's protocol ID
- 14-000218
- Status last verified
- Sep 2017
- First submitted
- 20 Mar 2014
- Last updated
- 2 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Waterproof Casting for Pediatric Distal Radius Fractures
- ClinicalTrials.gov ID
- NCT02095106
- Acronym / sponsor ID
- 14-000218
- Conditions
- Pediatric Distal Radius Fractures
- Keywords
- forearm fractures, pediatric fractures, distal radius
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Mar 2014 (estimated)
- Results
- Posted 2 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional cast first | Other | Device: Waterproof Cast, Device: Traditional castPatients 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. |
| Waterproof cast first | Other | Device: Waterproof Cast, Device: Traditional castPatients 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. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Waterproof CastAlso: HM Cast | Device | Traditional cast first, Waterproof cast first |
| Traditional castAlso: 3M Traditional fiberglass cast | Device | Traditional cast first, Waterproof cast first |
Primary outcome
Number of Participants Without Fracture Displacement at 8 Weeks Post Injury
Time frame: 8 weeks post injury
The radiographs at Week 8 were compared with initial radiographs to assess fracture displacement and angulation.
1 secondary outcome
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)
Time frame: 4 weeks post-injury
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauricio Silva, MD principal investigator
UCLA, Orthopaedic Institute for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Waterproof Cast and Traditional cast in people with Pediatric Distal Radius Fractures, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Without Fracture Displacement at 8 Weeks Post Injury (time frame: 8 weeks post injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.