Upper Limb FractureNCT06102603
Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children
A study testing the biobased polyester cast and the synthetic fiberglass cast in people with Upper Limb Fracture, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Upper Limb Fracture
- What is being tested?
- the biobased polyester cast and the synthetic fiberglass cast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jan 2022to 28 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Upper Limb Fracture
- Being tested
- the biobased polyester cast, the synthetic fiberglass cast
- Keywords
- Pediatric upper limb fracture, casting, Bioabased polyester, Synthetic cast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the biobased polyester castOther
long arm casting
the synthetic fiberglass castOther
long arm casting
| Study group | Role | What they receive |
|---|---|---|
| the biobased polyester cast group | Experimental | biobased polyester cast was applied Receives: Other: the biobased polyester cast |
| the synthetic fiberglass cast group | Active comparator | synthetic fiberglass cast was applied Receives: Other: the synthetic fiberglass cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patients with fracture union
clinical outcome
Measured: one month after intervention
the number of complications
clinical outcome
Measured: one month after intervention
patient satisfaction questionnaire
Measured: one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start27 Jan 2022
- Primary completion28 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper Limb FractureStudies of the same condition, open and under way.
- 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
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tsungyu Lan, Study chair, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102603
- Sponsor's protocol ID
- 110245-F
- Status last verified
- Sep 2023
- First submitted
- 17 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the study protocol could be shared
Publications
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.
PubMed 38166834
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobased Polyester Versus Synthetic Fiberglass Casts for Treating Stable Upper Limb Fractures in Children: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06102603
- Acronym / sponsor ID
- 110245-F
- Conditions
- Upper Limb Fracture
- Keywords
- Pediatric upper limb fracture, casting, Bioabased polyester, Synthetic cast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 28 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| the biobased polyester cast group | Experimental | Other: the biobased polyester castbiobased polyester cast was applied |
| the synthetic fiberglass cast group | Active comparator | Other: the synthetic fiberglass castsynthetic fiberglass cast was applied |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| the biobased polyester castlong arm casting | Other | the biobased polyester cast group |
| the synthetic fiberglass castlong arm casting | Other | the synthetic fiberglass cast group |
Primary outcome
the number of patients with fracture union
Time frame: one month after intervention
clinical outcome
the number of complications
Time frame: one month after intervention
clinical outcome
patient satisfaction questionnaire
Time frame: one month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Derived from this study: PubMed 38166834Lan 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.
- Individual participant dataSharing planned: Yes. the study protocol could be shared
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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.
Tsungyu Lan study chair
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the biobased polyester cast and the synthetic fiberglass cast in people with Upper Limb Fracture, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 4 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 30 Oct 2023. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the number of patients with fracture union (time frame: one month after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06102603, which also lists 1 linked publication.
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 30 Oct 2023.