Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children
| Registry | NCT03297047 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 120 (Actual) |
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| Sponsor | University Children's Hospital, Zurich (Other) |
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| Conditions | Salter-Harris Type I, Salter-Harris Type 2, Radius Fractures, Forearm Fracture |
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| Interventions | combi cast (Device) |
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| Dates | start 2017-10-02, primary completion 2019-08-29, completion 2019-08-29, first posted 2017-09-29, last updated 2019-09-17 |
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| Locations | 1 site in Switzerland |
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-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.
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+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.
+Arms and interventions
| Arm | Type | Interventions | Description |
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| upper arm combi cast | Active comparator | Device: combi cast | standardized treatment |
| forearm combi cast | Experimental | Device: combi cast | Treatment with a forearm combi cast should be a sufficient immobilization |
- combi cast (Device): upper arm or forearm combi cast
+Outcome measures
Primary outcomes
- secondary displacement of the fracture [Significant difference of secondary displaced fractures 28 days after closed reduction of fracture]: radiological evaluation
Secondary outcomes
- Wearing comfort of the two different casts [5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture]: help in daily life in hours
- Mobilisation of elbow joint after cast removal [4 weeks and 7 weeks after closed reduction of fracture]: Mobility of the elbow joint in degrees (flection and extension measurement)
+Eligibility
Sex: All, ages: 4 Years to 16 Years
Inclusion Criteria:
* open growth Zone
* displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction
* written informed consent
Exclusion Criteria:
* intraarticular fractures
* open fractures
* unstable fractures
+Locations (1)
| Facility | City | Country | Status |
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| Children's Hospital | Zurich | Switzerland | |
+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. PMID 21629372
- Webb 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. PMID 16391244
- Boyer 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. PMID 11856927
- Bhatia 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. PMID 16414049
- Katz 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. PMID 21590522
- Results publication: Seiler 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. PMID 32940750
+Investigators