Salter-Harris Type INCT03297047
Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children
A study testing combi cast in people with Salter-Harris Type I and Salter-Harris Type 2, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The standard treatment for children with closed reduction of displaced distal forearm fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm immobilization with combicast in children 4-16 years might be sufficient. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Salter-Harris Type I, Salter-Harris Type 2, Radius Fractures
- What is being tested?
- combi 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
- 2 Oct 2017to 29 Aug 2019
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- open growth Zone
- displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction
- written informed consent
Who cannot join
- intraarticular fractures
- open fractures
- unstable fractures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children
The standard treatment for children with closed reduction of displaced distal forearm fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm immobilization with combicast in children 4-16 years might be sufficient.
Read the detailed description
Children with distal radial or forearm fractures needing closed reduction are eligible for this study. By drawing lots either an immobilization with an upper arm or forearm combicast will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be performed to check the rate of displacement, consolidation time, wearing comfort and movement of the elbow joint after taking off the cast.
- Being tested
- combi cast
- Keywords
- cast, fracture, immobilization, displacement, child
- Medical subject headings
- Radius Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combi castDevice
upper arm or forearm combi cast
| Study group | Role | What they receive |
|---|---|---|
| upper arm combi cast | Active comparator | standardized treatment Receives: Device: combi cast |
| forearm combi cast | Experimental | Treatment with a forearm combi cast should be a sufficient immobilization Receives: Device: combi cast |
What is being measured
The primary outcome is the main question the study is designed to answer.
secondary displacement of the fracture
radiological evaluation
Measured: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
Secondary outcomes (2)
Wearing comfort of the two different casts
help in daily life in hours
Measured: 5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
Mobilisation of elbow joint after cast removal
Mobility of the elbow joint in degrees (flection and extension measurement)
Measured: 4 weeks and 7 weeks after closed reduction of fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start2 Oct 2017
- Primary completion29 Aug 2019
- Study completion29 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Salter-Harris Type IStudies 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
- one Group with upper arm cast one Group with forearm cast
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Staubli, University Children's Hospital, Zurich
- Investigators
- Georg Staubli, Dr. med, Principal investigator, Emergency department, University Children's Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297047
- Sponsor's protocol ID
- Forearm combi cast 2016
- Status last verified
- Sep 2019
- First submitted
- 27 Jul 2017
- Last updated
- 17 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paneru SR, Rijal R, Shrestha BP, Nepal P, Khanal GP, Karn NK, Singh MP, Rai P. Randomized controlled trial comparing above- and below-elbow plaster casts for distal forearm fractures in children. J Child Orthop. 2010 Jun;4(3):233-7. doi: 10.1007/s11832-010-0250-1. Epub 2010 Mar 17.
PubMed 21629372Webb GR, Galpin RD, Armstrong DG. Comparison of short and long arm plaster casts for displaced fractures in the distal third of the forearm in children. J Bone Joint Surg Am. 2006 Jan;88(1):9-17. doi: 10.2106/JBJS.E.00131.
PubMed 16391244Boyer BA, Overton B, Schrader W, Riley P, Fleissner P. Position of immobilization for pediatric forearm fractures. J Pediatr Orthop. 2002 Mar-Apr;22(2):185-7.
PubMed 11856927Bhatia M, Housden PH. Re-displacement of paediatric forearm fractures: role of plaster moulding and padding. Injury. 2006 Mar;37(3):259-68. doi: 10.1016/j.injury.2005.10.002. Epub 2006 Jan 18.
PubMed 16414049Katz K, Weigl D, Becker T, Attias J, Bar-On E. Short-term after-effect of forearm cast removal in children. J Orthop Sci. 2011 May;16(3):283-5. doi: 10.1007/s00776-011-0054-2. Epub 2011 Mar 29.
PubMed 21590522Seiler M, Heinz P, Callegari A, Dreher T, Staubli G, Aufdenblatten C. Short and long-arm fiberglass cast immobilization for displaced distal forearm fractures in children: a randomized controlled trial. Int Orthop. 2021 Mar;45(3):759-768. doi: 10.1007/s00264-020-04800-w. Epub 2020 Sep 17.
PubMed 32940750
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children
- ClinicalTrials.gov ID
- NCT03297047
- Acronym / sponsor ID
- Forearm combi cast 2016
- Keywords
- cast, fracture, immobilization, displacement, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 29 Aug 2019 (actual)
- Study completion
- 29 Aug 2019 (actual)
- First posted
- 29 Sep 2017 (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 standard treatment for children with closed reduction of displaced distal forearm fractures is an immobilization with an upper arm combicast. The hypothesis is that an forearm immobilization with combicast in children 4-16 years might be sufficient.
Detailed description
Children with distal radial or forearm fractures needing closed reduction are eligible for this study. By drawing lots either an immobilization with an upper arm or forearm combicast will be performed. Regular controls after 5, 10, 28 days, 4 weeks and 7 weeks will be performed to check the rate of displacement, consolidation time, wearing comfort and movement of the elbow joint after taking off the cast.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- one Group with upper arm cast one Group with forearm cast
| Arm | Type | Receives |
|---|---|---|
| upper arm combi cast | Active comparator | Device: combi caststandardized treatment |
| forearm combi cast | Experimental | Device: combi castTreatment with a forearm combi cast should be a sufficient immobilization |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- open growth Zone
- displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction
- written informed consent
Key exclusion criteria (3 listed)
- intraarticular fractures
- open fractures
- unstable fractures
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 |
|---|---|---|
| combi castupper arm or forearm combi cast | Device | forearm combi cast, upper arm combi cast |
Primary outcome
secondary displacement of the fracture
Time frame: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
radiological evaluation
2 secondary outcomes
Wearing comfort of the two different casts
Time frame: 5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
Mobilisation of elbow joint after cast removal
Time frame: 4 weeks and 7 weeks after closed reduction of fracture
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 17 Sep 2019.
- Background: PubMed 21629372Paneru SR, Rijal R, Shrestha BP, Nepal P, Khanal GP, Karn NK, Singh MP, Rai P. Randomized controlled trial comparing above- and below-elbow plaster casts for distal forearm fractures in children. J Child Orthop. 2010 Jun;4(3):233-7. doi: 10.1007/s11832-010-0250-1. Epub 2010 Mar 17.
- Background: PubMed 16391244Webb GR, Galpin RD, Armstrong DG. Comparison of short and long arm plaster casts for displaced fractures in the distal third of the forearm in children. J Bone Joint Surg Am. 2006 Jan;88(1):9-17. doi: 10.2106/JBJS.E.00131.
- Background: PubMed 11856927Boyer BA, Overton B, Schrader W, Riley P, Fleissner P. Position of immobilization for pediatric forearm fractures. J Pediatr Orthop. 2002 Mar-Apr;22(2):185-7.
- Background: PubMed 16414049Bhatia M, Housden PH. Re-displacement of paediatric forearm fractures: role of plaster moulding and padding. Injury. 2006 Mar;37(3):259-68. doi: 10.1016/j.injury.2005.10.002. Epub 2006 Jan 18.
- Background: PubMed 21590522Katz K, Weigl D, Becker T, Attias J, Bar-On E. Short-term after-effect of forearm cast removal in children. J Orthop Sci. 2011 May;16(3):283-5. doi: 10.1007/s00776-011-0054-2. Epub 2011 Mar 29.
- Derived from this study: PubMed 32940750Seiler M, Heinz P, Callegari A, Dreher T, Staubli G, Aufdenblatten C. Short and long-arm fiberglass cast immobilization for displaced distal forearm fractures in children: a randomized controlled trial. Int Orthop. 2021 Mar;45(3):759-768. doi: 10.1007/s00264-020-04800-w. Epub 2020 Sep 17.
- Individual participant dataSharing planned: No
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.
Georg Staubli, Dr. med principal investigator
Emergency department, 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 combi cast in people with Salter-Harris Type I and Salter-Harris Type 2, 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 3 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: finished, as of the sponsor's last update on 17 Sep 2019. 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?
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?
secondary displacement of the fracture (time frame: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture). 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 NCT03297047, which also lists 6 linked publications.
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 17 Sep 2019.