Fast Track for Wrist and Scaphoid Fractures

Wrist Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183477
• Other study ID #: 2021-02140
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: December 31, 2027

Study information

• Verified date: December 2023
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Laura Uccella, MD
• Phone: 0041918116657
• Email: laura.uccella[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 712
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Scaphoid Fracture
• Wrist Fracture
• Wrist Fractures

Intervention

Other:
• fast track
short cut for the request of xrays directly at triage
• normal pathway
x-ray would be required according to doctor's clinical evaluation.

Locations

Country	Name	City	State
Switzerland	Ospedale Regionale di Lugano - ORL	Lugano	Ticino

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of x rays requested	the number of xray requested	From admission to discharge, up to 2.5 hours
Secondary	waiting time before examination		From admission to discharge, up to 2.5 hours
Secondary	waiting time before xray		From admission to discharge, up to 2.5 hours
Secondary	total length of stay in the emergency department		From admission to discharge, up to 2.5 hours
Secondary	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