Clinical trial NCT05183477: Fast Track for Wrist and Scaphoid Fractures
Official title: Fast Track in the Emergency Department for Wrist and Scaphoid Fractures: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wrist Fracture
Scaphoid Fracture
Lead sponsor: Ente Ospedaliero Cantonale, Bellinzona
Sponsor class: OTHER
First posted: 2022-01-10
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of x rays requested
timeFrame: From admission to discharge, up to 2.5 hours
Secondary outcomes:
measure: waiting time before examination
timeFrame: From admission to discharge, up to 2.5 hours
measure: waiting time before xray
timeFrame: From admission to discharge, up to 2.5 hours
measure: total length of stay in the emergency department
timeFrame: From admission to discharge, up to 2.5 hours
measure: patient's satisfaction
timeFrame: From admission to discharge, up to 2.5 hours
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano - ORL
state: Ticino
Study officials:
affiliation: Ente Ospedaliero Cantonale, Bellinzona
name: Laura Uccella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.