Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT06102603
Status:
COMPLETED
Last Update Posted:
2023-10-30
First Post:
2023-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children
Sponsor:
Far Eastern Memorial Hospital
Organization:
Study Overview
Official Title:
Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2023-09
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:
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: