An interventional study of combi cast in Salter-Harris Type I, Salter-Harris Type 2 and Radius Fractures, sponsored by University Children's Hospital, Zurich. Completed at 1 site in Switzerland. Open to participants aged 4 Years to 16 Years. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by University Children's Hospital, Zurich · Not applicable, Interventional, and Treatment
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.
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.
62 studies on the registry are indexed under Radius Fractures; 6 are open to participants now.
This study's enrollment of 120 is above the median of 60 across 48 interventional studies indexed under Radius Fractures.
Browse Radius Fractures studies →University Children's Hospital, Zurich is the lead sponsor of 95 studies on the registry; 23 are open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
standardized treatment
Device: combi cast
Treatment with a forearm combi cast should be a sufficient immobilization
Device: combi cast
upper arm or forearm combi cast
secondary displacement of the fracture
radiological evaluation
Time frame: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
Wearing comfort of the two different casts
help in daily life in hours
Time frame: 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)
Time frame: 4 weeks and 7 weeks after closed reduction of fracture
Plan to share: No
Ran from Oct 2017 to primary completion in Aug 2019, 22 months.
Of 14 interventional studies with no phase under Radius Fractures, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's 22 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University Children's Hospital, Zurich