Wrist InjuriesNCT07553000
Splinted Wrist Study
A study testing SAM splint in people with Wrist Injuries and Wrist Fracture, run by Region Skane at 1 site in Sweden.
Trial summary
Randomized clinical trial comparing SAM aluminium splint vs pain relief as usual in patients seeking emergency department care for suspected wrist fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Injuries, Wrist Fracture, Pain, Acute
- What is being tested?
- SAM splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- 14 Dec 2022to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- NRS 5-10
- Suspected distal fracture of radius
Who cannot join
- No X-ray veriefied fracture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Emergency department, Malmö university hospital
Malmö, 20502
Per Köhler, Phd, +46(0)40338481, per.kohler@skane.se
Olof Fager, Msc, +46(0)40331000, olof.o.fager@skane.se
About this study
Official title: The Additional Pain Relieving Benefit of Using a Splint in Suspected Wrist Fractures in Adult Patients at an Emergency Department - a Randomized Controlled Trial.
Randomized clinical trial comparing SAM aluminium splint vs pain relief as usual in patients seeking emergency department care for suspected wrist fractures.
Read the detailed description
Randomized controlled trial of suspected wrist fractures in patients seeking emergency department care. Comparison of pain relief. Randomized to standard care or standard care + aluminium splint.
Primary outcome: Numeric rating scale (NRS) pain rating at 1 hour. Secondary outcomes: Pain medication usage between groups. Negative impact on radiology results.
Safety endpoint: Reported side effects
- Conditions
- Wrist Injuries, Wrist Fracture, Pain, Acute
- Being tested
- SAM splint
- Medical subject headings
- Wrist Injuries, Wrist Fractures, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAM splintDevice
Splint vs no splint in paitents awaiting X-ray in the ER.
| Study group | Role | What they receive |
|---|---|---|
| SAM splint | Active comparator | Recieves SAM splint for pain relief Receives: Device: SAM splint |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment
Self assessed pain according to NRS (numeric rating scale)
Measured: 60 minutes
Secondary outcomes (3)
Pain relief medication
Between-group comparison of analgesia provided by nursing staff up to 24 hours after presentation at ER.
Measured: 24 hours from enrollment.
Negative impact on radiology
Splint artefacts on radiological exam.
Measured: 24 hours from enrollment in study.
Adverse events
Side effects from splint
Measured: 24 from enrollment in ER.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start14 Dec 2022
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist InjuriesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SAM wrist splint
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553000
- Sponsor's protocol ID
- 5.1-2022-89331.
- Status last verified
- Feb 2026
- First submitted
- 4 Jan 2023
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IDP collected will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Additional Pain Relieving Benefit of Using a Splint in Suspected Wrist Fractures in Adult Patients at an Emergency Department - a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07553000
- Acronym / sponsor ID
- 5.1-2022-89331.
- Conditions
- Wrist Injuries, Wrist Fracture, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 14 Dec 2022 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 Apr 2026 (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.
Randomized clinical trial comparing SAM aluminium splint vs pain relief as usual in patients seeking emergency department care for suspected wrist fractures.
Detailed description
Randomized controlled trial of suspected wrist fractures in patients seeking emergency department care. Comparison of pain relief. Randomized to standard care or standard care + aluminium splint.
Primary outcome: Numeric rating scale (NRS) pain rating at 1 hour. Secondary outcomes: Pain medication usage between groups. Negative impact on radiology results.
Safety endpoint: Reported side effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- SAM wrist splint
| Arm | Type | Receives |
|---|---|---|
| SAM splint | Active comparator | Device: SAM splintRecieves SAM splint for pain relief |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- NRS 5-10
- Suspected distal fracture of radius
Key exclusion criteria (1 listed)
- No X-ray veriefied fracture.
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 |
|---|---|---|
| SAM splintSplint vs no splint in paitents awaiting X-ray in the ER. | Device | SAM splint |
Primary outcome
Pain assessment
Time frame: 60 minutes
Self assessed pain according to NRS (numeric rating scale)
3 secondary outcomes
Pain relief medication
Time frame: 24 hours from enrollment.
Negative impact on radiology
Time frame: 24 hours from enrollment in study.
Adverse events
Time frame: 24 from enrollment in ER.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: Yes. All IDP collected will be shared upon request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SAM splint in people with Wrist Injuries and Wrist Fracture, run by Region Skane at 1 site in Sweden.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assessment (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2026.