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RecruitingNCT07553000Updated Apr 27, 2026

Splinted Wrist Study

An interventional study of SAM splint in Wrist Injuries, Wrist Fracture and Pain, Acute, sponsored by Region Skane. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-27.

Primary conditionWrist FracturesRegistry: Wrist InjuriesReclassifiedWhy we changed it
Registry
Wrist Injuries — the first condition term the registry derived for this study.
ClinicalTrials.gg
Wrist Fractures
Why
  1. The study's listed conditions name Wrist Fractures, a narrower term within Wrist Injuries.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Region Skane · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Wrist Injuries
  • Wrist Fracture
  • Pain, Acute

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03

In context

Wrist Fractures Reclassified

330 studies on the registry are indexed under Wrist Fractures; 73 are open to participants now.

This study's planned enrollment of 120 is above the median of 62 across 265 interventional studies indexed under Wrist Fractures.

Browse Wrist Fractures studies →

Lead sponsor

Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.

Browse Region Skane studies →

Compared within Wrist Fractures, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Wrist Injuries. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • NRS 5-10
  • Suspected distal fracture of radius

Exclusion criteria

Exclusion Criteria:

  • No X-ray veriefied fracture.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    SAM splint

    Recieves SAM splint for pain relief

    Device: SAM splint

  • No intervention
    Control

    Treatment as usual

Interventions

  • DeviceSAM splint

    Splint vs no splint in paitents awaiting X-ray in the ER.

06

What researchers measure

Primary outcomes

  1. Pain assessment

    Self assessed pain according to NRS (numeric rating scale)

    Time frame: 60 minutes

Secondary outcomes

  1. Pain relief medication

    Between-group comparison of analgesia provided by nursing staff up to 24 hours after presentation at ER.

    Time frame: 24 hours from enrollment.

  2. Negative impact on radiology

    Splint artefacts on radiological exam.

    Time frame: 24 hours from enrollment in study.

  3. Adverse events

    Side effects from splint

    Time frame: 24 from enrollment in ER.

07

Study locations

1 of 1 sites recruiting
  • Emergency department, Malmö university hospital
    Malmö, 20502, Sweden
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All IDP collected will be shared upon request.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2022 (actual). Primary completion is estimated for Dec 2026, 48 months after the start.

Of 125 non-industry interventional studies with no phase under Wrist Fractures, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 50. This study's planned 48 months is above that.

Counting every sponsor, half of 126 studies reached it within 26 months; a quarter within 16 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 4, 2023
First posted
Apr 27, 2026
StartActual
Dec 14, 2022
Primary completionEst.
Dec 30, 2026
CompletionEst.
Dec 30, 2027
Last update
Apr 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07553000
Lead sponsor
Region Skane
Responsible party
Sponsor
First posted
Apr 27, 2026
Start date
Dec 14, 2022
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Apr 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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