NCT05183477

Brief Summary

This is a mono centric, prospective, randomised trial on the implementation and assessment of a shortened pathway for mono-trauma of the wrist and suspected fracture of distal radius and/or ulna and/or scaphoid bone.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
196

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

December 7, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

December 17, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

2.8 years

First QC Date

December 7, 2021

Last Update Submit

February 25, 2025

Conditions

Wrist FractureScaphoid Fracture

Outcome Measures

Primary Outcomes (1)

  • number of x rays requested

    the number of xray requested

    From admission to discharge, up to 2.5 hours

Secondary Outcomes (4)

  • waiting time before examination

    From admission to discharge, up to 2.5 hours

  • waiting time before xray

    From admission to discharge, up to 2.5 hours

  • total length of stay in the emergency department

    From admission to discharge, up to 2.5 hours

  • patient's satisfaction

    From admission to discharge, up to 2.5 hours

Study Arms (2)

fast track

EXPERIMENTAL

patients arriving at Emergency Department with suspected wrist or scaphoid fracture, randomly allocated to the fast track pathway (xray requested at triage by nurse)

Other: fast track

normal pathway

ACTIVE COMPARATOR

patients arriving at Emergency Department with suspected wrist or scaphoid fracture, randomly allocated to waiting room and than medical examination before asking for xrays

Other: normal pathway

Interventions

fast trackOTHER

short cut for the request of xrays directly at triage

fast track
normal pathwayOTHER

x-ray would be required according to doctor's clinical evaluation.

normal pathway

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults patients presenting at the emergency dept with suspected scaphoid or wrist fracture
  • monotrauma
  • written informed consent

You may not qualify if:

  • patients younger than 18 yr
  • pregnant women
  • either vascular or neural impairment
  • signs of open fracture
  • multiple trauma patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale Regionale di Lugano - ORL

Lugano, Canton Ticino, 6900, Switzerland

Location

Related Publications (5)

  • Mallee WH, Walenkamp MMJ, Mulders MAM, Goslings JC, Schep NWL. Detecting scaphoid fractures in wrist injury: a clinical decision rule. Arch Orthop Trauma Surg. 2020 Apr;140(4):575-581. doi: 10.1007/s00402-020-03383-w. Epub 2020 Mar 3.

    PMID: 32125528BACKGROUND

  • Walenkamp MM, Bentohami A, Slaar A, Beerekamp MS, Maas M, Jager LC, Sosef NL, van Velde R, Ultee JM, Steyerberg EW, Goslings JC, Schep NW. The Amsterdam wrist rules: the multicenter prospective derivation and external validation of a clinical decision rule for the use of radiography in acute wrist trauma. BMC Musculoskelet Disord. 2015 Dec 18;16:389. doi: 10.1186/s12891-015-0829-2.

    PMID: 26682537BACKGROUND

  • Chudleigh J. Nurse requested X-rays in A&E department. Emerg Nurse. 2004 Feb;11(9):32-6. doi: 10.7748/en2004.02.11.9.32.c1146. No abstract available.

    PMID: 15000019BACKGROUND

  • Streppa J, Schneidman V, Biron AD. Requesting wrist radiographs in emergency department triage: developing a training program and diagnostic algorithm. Adv Emerg Nurs J. 2014 Jan-Mar;36(1):62-77. doi: 10.1097/TME.0000000000000005.

    PMID: 24487265BACKGROUND

  • van den Brand CL, van Leerdam RH, van Ufford JH, Rhemrev SJ. Is there a need for a clinical decision rule in blunt wrist trauma? Injury. 2013 Nov;44(11):1615-9. doi: 10.1016/j.injury.2013.07.006. Epub 2013 Jul 31.

    PMID: 23915492BACKGROUND

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Laura Uccella, MD

    Ente Ospedaliero Cantonale, Bellinzona

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 7, 2021

First Posted

January 10, 2022

Study Start

December 17, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations

CH(1)