Upper Limb Fracture
Conditions
Keywords
Pediatric upper limb fracture, casting, Bioabased polyester, Synthetic cast
Brief summary
From Feb 2022 to Nov 2022, we undertook a single-center prospective randomized trial involving 100 children with cast-immobilized stable upper limb fractures. These patients were randomized into either biobased polyester or synthetic fiberglass groups. All patients were regularly followed up till the cast removal which occurred approximately 3-4 weeks after immobilizing. Objective clinical findings and subjective patient questionnaire were all collected and analyzed.
Detailed description
The clinical trial was approved by the research ethics review committee of the author's hospital and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) \[9\] diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.
Interventions
OTHERthe biobased polyester cast
long arm casting
OTHERthe synthetic fiberglass cast
long arm casting
Sponsors
Far Eastern Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
The clinical trial was approved by the research ethics review committee of the author's hospital (Number XXX) and informed consent was obtained from the legal guardian of each patient. Between Feb 2022 and Nov 2022, all children (age range, 4-15 years) with radiography-diagnosed stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I9 supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital were eligible for recruitment.
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* stable upper limb fractures (including radius, ulna, and distal humerus fractures such as Garland type I supracondylar fractures of the humerus) diagnosed at the orthopedic outpatient clinic or emergency room of a tertiary trauma center hospital
Exclusion criteria
* displaced or unstable fractures indicated for close or open reduction and fixation * previous surgeries to the affected upper limb * history of any chronic skin pathology (e.g., atopic dermatitis) * known allergy to cast materials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the number of patients with fracture union | one month after intervention | clinical outcome |
| the number of complications | one month after intervention | clinical outcome |
| patient satisfaction questionnaire | one month after intervention | — |
Countries
Taiwan
Outcome results
None listed