Clinical trial NCT03297047: Comparing Forearm and Upper Arm Combi Cast for Distal Forearm Fractures in Children
Official title: Randomized Controlled Trial Comparing Forearm and Upper Arm Combi Cast for Immobilization After Closed Reduced Distal Forearm Fractures in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Salter-Harris Type I
Salter-Harris Type 2
Radius Fractures
Forearm Fracture
Keywords: cast, fracture, immobilization, displacement, child
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2017-09-29
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: one Group with upper arm cast one Group with forearm cast
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: secondary displacement of the fracture
timeFrame: Significant difference of secondary displaced fractures 28 days after closed reduction of fracture
Secondary outcomes:
measure: Wearing comfort of the two different casts
timeFrame: 5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture
measure: Mobilisation of elbow joint after cast removal
timeFrame: 4 weeks and 7 weeks after closed reduction of fracture
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Children's Hospital
Study officials:
affiliation: Emergency department, University Children's Hospital Zurich
name: Georg Staubli, Dr. med
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.