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

NCT05156749 | Recruiting

• 1 other identifier: UChildrenZurich_salter harris
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture Forearm

Outcome Measures

Primary Outcomes (1)

• Rate of fracture displacement

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

  in the first four weeks after trauma

Study Arms (2)

short-arm fiberglass cast

EXPERIMENTAL

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

long-arm fiberglass cast

ACTIVE COMPARATOR

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

Interventions

short-arm fiberglass cast DEVICE

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

short-arm fiberglass cast

long-arm fiberglass cast DEVICE

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

long-arm fiberglass cast

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Salter Harris I or II fracture of the distal radius or a forearm fracture
• informed consent

You may not qualify if:

• open/instable/intraarticular fracture
• age \<4 years or \> 16years
• no informed consent

Sponsors & Collaborators

• University Children's Hospital, Zurich: lead

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8032, Switzerland

RECRUITING

Study Officials

• Michelle Seiler, PD

  University Children's Hospital, Zurich

  STUDY CHAIR

Central Study Contacts

Michelle Seiler, PD

CONTACT

+41 44 266 43 10; michelle.seiler@kispi.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 14, 2021
• Study Start: December 7, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)