Fast Track for Wrist and Scaphoid Fractures

Fast Track in the Emergency Department for Wrist and Scaphoid Fractures: a Randomised Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Wrist Fracture; Scaphoid Fracture
• Intervention / Treatment: Other: fast track; Other: normal pathway

Detailed Description

Patients will be randomised into two groups: fast track and normal pathway. At the arrival in the Emergency Department a triage will be performed. In case of met inclusion criteria the patient will sign the informed consent and will be randomised in one of the two study groups.

The fast track group will be straightforwardly evaluated for absence of exclusion criteria (in case of exclusion criteria present the investigators will follow the normal pathway and the patient will not be included in the study). Then, patients will be assessed with an ad hoc checklist and then sent for x-ray performance, if necessary. After the x-ray the patients will be examined by an emergency physician that will have the opportunity to request new x-ray views if necessary.

The normal pathway group will go straight to medical examination as soon as possible, depending on waiting times in the Emergency Department.

Investigators will collect anagraphical data, waiting times, time to x-ray, overall length of stay in the Emergency Department, patients' and staff's satisfaction for the two groups.

• Study Type: Interventional
• Enrollment (Estimated): 712
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Uccella, MD; Phone Number: 0041918116657; Email: laura.uccella@eoc.ch

Study Locations

• Switzerland
  • Ticino
    • Lugano, Ticino, Switzerland, 6900
      • Recruiting
      • Ospedale Regionale di Lugano - ORL
      • Contact: laura uccella; Phone Number: +41918116657; Email: zebru73@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: fast track; 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; short cut for the request of xrays directly at triage
Active Comparator: normal pathway; 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; x-ray would be required according to doctor's clinical evaluation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of x rays requested	the number of xray requested	From admission to discharge, up to 2.5 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Patients' satisfaction will be tested with the help of the brief emergency department patient satisfaction scale (BEPSS). The questionnaire consists of 20 questions and for each item, a response scale form 1 (completely disagree) to 4 (completely agree) is used.	From admission to discharge, up to 2.5 hours

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona
• Investigators: Principal Investigator: Laura Uccella, MD, Ente Ospedaliero Cantonale, Bellinzona

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2021
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 7, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Arm Injuries; Wrist Injuries; Fractures, Bone; Wrist Fractures
• Other Study ID Numbers: 2021-02140

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: no plan at the moment

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No