Fast Track for Wrist and Scaphoid Fractures

NCT ID: NCT05183477

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

196 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-17

Study Completion Date

2024-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Wrist Fracture Scaphoid Fracture

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Group Type EXPERIMENTAL

fast track

Intervention Type OTHER

short cut for the request of xrays directly at triage

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

Group Type ACTIVE_COMPARATOR

normal pathway

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fast track

short cut for the request of xrays directly at triage

Intervention Type OTHER

normal pathway

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ente Ospedaliero Cantonale, Bellinzona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Laura Uccella, MD

Role: PRINCIPAL_INVESTIGATOR

Ente Ospedaliero Cantonale, Bellinzona

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ospedale Regionale di Lugano - ORL

Lugano, Canton Ticino, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 32125528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26682537 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15000019 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24487265 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23915492 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-02140

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.