Fracture ForearmNCT05156749
Short and Long-arm Fiberglass Cast Immobilization for Distal Salter Harris I and II Forearm Fractures in Children
A study testing short-arm fiberglass cast and long-arm fiberglass cast in people with Fracture Forearm, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Fracture Forearm
- What is being tested?
- short-arm fiberglass cast and long-arm fiberglass cast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Dec 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Salter Harris I or II fracture of the distal radius or a forearm fracture
- informed consent
Who cannot join
- open/instable/intraarticular fracture
- age <4 years or > 16years
- no informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital Zurich
Zurich, 8032
Michelle Seiler, MD, +41 44 266 32 10, michelle.seiler@kispi.uzh.ch
About this study
Official title: Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen im Kindesalter
The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients.
Read the detailed description
The patients are allocated randomly into the two groups(short-arm cast, long-arm cast). After confirming study participation, patients draw a sealed envelope enclosing a numbered card, which assignes them to one group or other. After choosing the envelope, neither the ED staff nor the parents and their childrenare blinded for the treatment groups. However, the data are going to be analyzed under blinded conditions
- Conditions
- Fracture Forearm
- Being tested
- short-arm fiberglass cast, long-arm fiberglass cast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short-arm fiberglass castDevice
fracture stabilization of salter harris I/II fractures with a fiberglass short-arm cast
long-arm fiberglass castDevice
fracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast
| Study group | Role | What they receive |
|---|---|---|
| short-arm fiberglass cast | Experimental | salter harris fractures of the distal radius/forearm in children are usually treated with fiberglass long-arm casts. The investigators were able to demonstrate that in distal metaphyseal forearm fracture, treatment with a short-arm cast is not inferior to a long-arm cast.
Patients are going to receive a short-arm cast for fracture treatment. Receives: Device: short-arm fiberglass cast |
| long-arm fiberglass cast | Active comparator | salter harris fractures of the distal radius/forearm in children are usually treated with a fiberglass long-arm cast.
Patients are going to receive a long-arm cast for fracture treatment. Receives: Device: long-arm fiberglass cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fracture displacement
difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)
Measured: in the first four weeks after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start7 Dec 2021
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture ForearmStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Seiler, PD, Study chair, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156749
- Sponsor's protocol ID
- UChildrenZurich_salter harris
- Status last verified
- Apr 2026
- First submitted
- 29 Nov 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen im Kindesalter
- ClinicalTrials.gov ID
- NCT05156749
- Acronym / sponsor ID
- UChildrenZurich_salter harris
- Conditions
- Fracture Forearm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 14 Dec 2021 (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.
The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients.
Detailed description
The patients are allocated randomly into the two groups(short-arm cast, long-arm cast). After confirming study participation, patients draw a sealed envelope enclosing a numbered card, which assignes them to one group or other. After choosing the envelope, neither the ED staff nor the parents and their childrenare blinded for the treatment groups. However, the data are going to be analyzed under blinded conditions
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| short-arm fiberglass cast | Experimental | Device: short-arm fiberglass castsalter harris fractures of the distal radius/forearm in children are usually treated with fiberglass long-arm casts. The investigators were able to demonstrate that in distal metaphyseal forearm fracture, treatment with a short-arm cast is not inferior to a long-arm cast. Patients are going to receive a short-arm cast for fracture treatment. |
| long-arm fiberglass cast | Active comparator | Device: long-arm fiberglass castsalter harris fractures of the distal radius/forearm in children are usually treated with a fiberglass long-arm cast. Patients are going to receive a long-arm cast for fracture treatment. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Salter Harris I or II fracture of the distal radius or a forearm fracture
- informed consent
Key exclusion criteria (3 listed)
- open/instable/intraarticular fracture
- age <4 years or > 16years
- no informed consent
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 |
|---|---|---|
| short-arm fiberglass castfracture stabilization of salter harris I/II fractures with a fiberglass short-arm cast | Device | short-arm fiberglass cast |
| long-arm fiberglass castfracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast | Device | long-arm fiberglass cast |
Primary outcome
Rate of fracture displacement
Time frame: in the first four weeks after trauma
difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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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.
Michelle Seiler, PD study chair
University Children's Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short-arm fiberglass cast and long-arm fiberglass cast in people with Fracture Forearm, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 May 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Seiler, PD (+41 44 266 43 10, michelle.seiler@kispi.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fracture displacement (time frame: in the first four weeks after trauma). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2026.