NCT07553000

Brief Summary

Randomized clinical trial comparing SAM aluminium splint vs pain relief as usual in patients seeking emergency department care for suspected wrist fractures.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started Dec 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Dec 2022Dec 2027

Study Start

First participant enrolled

December 14, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2023

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

April 27, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 27, 2026

Status Verified

February 1, 2026

Enrollment Period

4 years

First QC Date

January 4, 2023

Last Update Submit

April 24, 2026

Conditions

Wrist FracturePain, AcuteWrist Injuries

Outcome Measures

Primary Outcomes (1)

  • Pain assessment

    Self assessed pain according to NRS (numeric rating scale)

    60 minutes

Secondary Outcomes (3)

  • Pain relief medication

    24 hours from enrollment.

  • Negative impact on radiology

    24 hours from enrollment in study.

  • Adverse events

    24 from enrollment in ER.

Study Arms (2)

SAM splint

ACTIVE COMPARATOR

Recieves SAM splint for pain relief

Device: SAM splint

Control

NO INTERVENTION

Treatment as usual

Interventions

SAM splintDEVICE

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

SAM splint

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • NRS 5-10
  • Suspected distal fracture of radius

You may not qualify if:

  • No X-ray veriefied fracture.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department, Malmö university hospital

Malmo, 20502, Sweden

RECRUITING

MeSH Terms

Conditions

Wrist InjuriesWrist FracturesAcute Pain

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, BonePainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: SAM wrist splint
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2023

First Posted

April 27, 2026

Study Start

December 14, 2022

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

April 27, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

All IDP collected will be shared upon request.

Locations

SE(1)