Ignite Creation Date:
2024-05-06 @ 2:40 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02095106
Status:
COMPLETED
Last Update Posted:
2017-12-02
First Post:
2014-03-20
Brief Title:
Waterproof Casting for Pediatric Distal Radius Fractures
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
Waterproof Casting for Pediatric Distal Radius Fractures
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n13 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
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 n13 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None