Short and Long-arm Fiberglass Cast Immobilization for Distal Salter Harris I and II Forearm Fractures in Children

Sponsor
University Children's Hospital, Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT05156749
Collaborator
(none)
120
1
2
31.8
3.8

Study Details

Study Description

Brief Summary

The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients.

Condition or Disease Intervention/Treatment Phase
  • Device: short-arm fiberglass cast
  • Device: long-arm fiberglass cast
N/A

Detailed Description

The patients are allocated randomly into the two groups(short-arm cast, long-arm cast). After confirming study participation, patients draw a sealed envelope enclosing a numbered card, which assignes them to one group or other. After choosing the envelope, neither the ED staff nor the parents and their childrenare blinded for the treatment groups. However, the data are going to be analyzed under blinded conditions

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen im Kindesalter
Actual Study Start Date :
Dec 7, 2021
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: short-arm fiberglass cast

salter harris fractures of the distal radius/forearm in children are usually treated with fiberglass long-arm casts. The investigators were able to demonstrate that in distal metaphyseal forearm fracture, treatment with a short-arm cast is not inferior to a long-arm cast. Patients are going to receive a short-arm cast for fracture treatment.

Device: short-arm fiberglass cast
fracture stabilization of salter harris I/II fractures with a fiberglass short-arm cast

Active Comparator: long-arm fiberglass cast

salter harris fractures of the distal radius/forearm in children are usually treated with a fiberglass long-arm cast. Patients are going to receive a long-arm cast for fracture treatment.

Device: long-arm fiberglass cast
fracture stabilization of salter harris I/II fractures with a fiberglass long-arm cast

Outcome Measures

Primary Outcome Measures

  1. Rate of fracture displacement [in the first four weeks after trauma]

    difference in fracture angulation values either at pre-treatment or during follow-up between the two groups (short-arm cast; long-arm cast)

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Salter Harris I or II fracture of the distal radius or a forearm fracture

  • informed consent

Exclusion Criteria:
  • open/instable/intraarticular fracture

  • age <4 years or > 16years

  • no informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Children's Hospital Zurich Zürich Switzerland 8032

Sponsors and Collaborators

  • University Children's Hospital, Zurich

Investigators

  • Study Chair: Michelle Seiler, PD, University Children's Hospital, Zurich

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Children's Hospital, Zurich
ClinicalTrials.gov Identifier:
NCT05156749
Other Study ID Numbers:
  • UChildrenZurich_salter harris
First Posted:
Dec 14, 2021
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022