Wrist FractureNCT05183477
Fast Track for Wrist and Scaphoid Fractures
A study testing fast track and normal pathway in people with Wrist Fracture and Scaphoid Fracture, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Fracture, Scaphoid Fracture
- What is being tested?
- fast track and normal pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSwitzerland
- Study dates
- 17 Dec 2021to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adults patients presenting at the emergency dept with suspected scaphoid or wrist fracture
- monotrauma
- written informed consent
Who cannot join
- patients younger than 18 yr
- pregnant women
- either vascular or neural impairment
- signs of open fracture
- multiple trauma patient
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Ospedale Regionale di Lugano - ORL
Lugano, Canton Ticino, 6900
About this study
Official title: 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.
Read the 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.
- Conditions
- Wrist Fracture, Scaphoid Fracture
- Being tested
- fast track, normal pathway
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast trackOther
short cut for the request of xrays directly at triage
normal pathwayOther
x-ray would be required according to doctor's clinical evaluation.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: normal pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of x rays requested
the number of xray requested
Measured: From admission to discharge, up to 2.5 hours
Secondary outcomes (4)
waiting time before examination
Measured: From admission to discharge, up to 2.5 hours
waiting time before xray
Measured: From admission to discharge, up to 2.5 hours
total length of stay in the emergency department
Measured: 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.
Measured: From admission to discharge, up to 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start17 Dec 2021
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Why it stopped: Investigator's departure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Wrist FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ente Ospedaliero Cantonale, Bellinzona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura Uccella, MD, Principal investigator, Ente Ospedaliero Cantonale, Bellinzona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183477
- Sponsor's protocol ID
- 2021-02140
- Status last verified
- Feb 2025
- First submitted
- 7 Dec 2021
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: no plan at the moment
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.
PubMed 32125528Walenkamp 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.
PubMed 26682537Chudleigh 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.
PubMed 15000019Streppa 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.
PubMed 24487265van 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.
PubMed 23915492
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Track in the Emergency Department for Wrist and Scaphoid Fractures: a Randomised Trial
- ClinicalTrials.gov ID
- NCT05183477
- Acronym / sponsor ID
- 2021-02140
- Conditions
- Wrist Fracture, Scaphoid Fracture
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator's departure
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Ente Ospedaliero Cantonale, BellinzonaUniversity, hospital or other
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fast track | Experimental | Other: fast trackpatients arriving at Emergency Department with suspected wrist or scaphoid fracture, randomly allocated to the fast track pathway (xray requested at triage by nurse) |
| normal pathway | Active comparator | Other: normal pathwaypatients arriving at Emergency Department with suspected wrist or scaphoid fracture, randomly allocated to waiting room and than medical examination before asking for xrays |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adults patients presenting at the emergency dept with suspected scaphoid or wrist fracture
- monotrauma
- written informed consent
Key exclusion criteria (5 listed)
- patients younger than 18 yr
- pregnant women
- either vascular or neural impairment
- signs of open fracture
- multiple trauma patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fast trackshort cut for the request of xrays directly at triage | Other | fast track |
| normal pathwayx-ray would be required according to doctor's clinical evaluation. | Other | normal pathway |
Primary outcome
number of x rays requested
Time frame: From admission to discharge, up to 2.5 hours
the number of xray requested
4 secondary outcomes
waiting time before examination
Time frame: From admission to discharge, up to 2.5 hours
waiting time before xray
Time frame: From admission to discharge, up to 2.5 hours
total length of stay in the emergency department
Time frame: From admission to discharge, up to 2.5 hours
patient's satisfaction
Time frame: From admission to discharge, up to 2.5 hours
Results and safety
The study was stopped early (reason given: Investigator's departure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Background: PubMed 32125528Mallee 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.
- Background: PubMed 26682537Walenkamp 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.
- Background: PubMed 15000019Chudleigh 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.
- Background: PubMed 24487265Streppa 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.
- Background: PubMed 23915492van 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.
- Individual participant dataSharing planned: Undecided. no plan at the moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Uccella, MD principal investigator
Ente Ospedaliero Cantonale, Bellinzona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fast track and normal pathway in people with Wrist Fracture and Scaphoid Fracture, run by Ente Ospedaliero Cantonale, Bellinzona at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator's departure). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of x rays requested (time frame: From admission to discharge, up to 2.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183477, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.