NCT03297047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 29, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2019

Completed
Last Updated

September 17, 2019

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

July 27, 2017

Last Update Submit

September 16, 2019

Conditions

Salter-Harris Type ISalter-Harris Type 2Radius FracturesForearm Fracture

Keywords

cast, fracture, immobilization, displacement, child

Outcome Measures

Primary Outcomes (1)

  • secondary displacement of the fracture

    radiological evaluation

    Significant difference of secondary displaced fractures 28 days after closed reduction of fracture

Secondary Outcomes (2)

  • Wearing comfort of the two different casts

    5, 10, 28 days, 4 weeks, 7 weeks after closed reduction of fracture

  • Mobilisation of elbow joint after cast removal

    4 weeks and 7 weeks after closed reduction of fracture

Study Arms (2)

upper arm combi cast

ACTIVE COMPARATOR

standardized treatment

Device: combi cast

forearm combi cast

EXPERIMENTAL

Treatment with a forearm combi cast should be a sufficient immobilization

Device: combi cast

Interventions

combi castDEVICE

upper arm or forearm combi cast

forearm combi castupper arm combi cast

Eligibility Criteria

Age4 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • open growth Zone
  • displaced metaphyseal radial or forearm fractures including Salter harris fracture 1 and 2 which require closed reduction
  • written informed consent

You may not qualify if:

  • intraarticular fractures
  • open fractures
  • unstable fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital

Zurich, 8032, Switzerland

Location

Related Publications (6)

  • 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: 21629372BACKGROUND

  • 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: 16391244BACKGROUND

  • 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: 11856927BACKGROUND

  • 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: 16414049BACKGROUND

  • 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: 21590522BACKGROUND

  • 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: 32940750DERIVED

MeSH Terms

Conditions

Radius FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Forearm InjuriesArm InjuriesWounds and Injuries

Study Officials

  • Georg Staubli, Dr. med

    Emergency department, University Children's Hospital Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: one Group with upper arm cast one Group with forearm cast
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

July 27, 2017

First Posted

September 29, 2017

Study Start

October 2, 2017

Primary Completion

August 29, 2019

Study Completion

August 29, 2019

Last Updated

September 17, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)