Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children

NCT06102603 | Completed

• 1 other identifier: 110245-F
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Limb Fracture

Keywords

Pediatric upper limb fracture; casting; Bioabased polyester; Synthetic cast

Outcome Measures

Primary Outcomes (3)

• the number of patients with fracture union

  clinical outcome

  one month after intervention

• the number of complications

  clinical outcome

  one month after intervention

• patient satisfaction questionnaire

  one month after intervention

Study Arms (2)

the biobased polyester cast group

EXPERIMENTAL

biobased polyester cast was applied

Other: the biobased polyester cast

the synthetic fiberglass cast group

ACTIVE COMPARATOR

synthetic fiberglass cast was applied

Other: the synthetic fiberglass cast

Interventions

the biobased polyester cast OTHER

long arm casting

the biobased polyester cast group

the synthetic fiberglass cast OTHER

long arm casting

the synthetic fiberglass cast group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memorial Hospital

New Taipei City, 220, Taiwan

Location

Related Publications (1)

• Lan TY, Chen CW, Huang YH, Lin SM, Liang CT, Chang CH, Rwei SP. Biobased polyester versus synthetic fiberglass casts for treating stable upper limb fractures in children: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Jan 2;25(1):23. doi: 10.1186/s12891-023-07138-7.

  PMID: 38166834 DERIVED

Study Officials

• Tsungyu Lan

  Far Eastern Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 26, 2023
• Study Start: January 27, 2022
• Primary Completion: September 28, 2022
• Study Completion: September 28, 2022
• Last Updated: October 30, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: one year

Locations

TW (1)