Splinted Wrist Study | NCT07553000

Studies
Splinted Wrist Study

NCT07553000

Sponsor

Region Skane

Status

Recruiting

Last Update Posted

Apr 27, 2026Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Wrist Injuries
Wrist Fracture
Pain, Acute

Interventions

SAM splint

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2022Actual

Primary Completion Date

Dec 30, 2026Estimated

Completion Date

Dec 30, 2027Estimated

First Submitted Date

Jan 4, 2023

First Submission Date that Met QC Criteria

Apr 24, 2026

First Posted Date

Apr 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2026

Last Update Posted Date

Apr 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SAM splint	Active Comparator	Recieves SAM splint for pain relief	Device: SAM splint
Control	No Intervention	Treatment as usual

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SAM splint	Device	Splint vs no splint in paitents awaiting X-ray in the ER.	SAM splint

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain assessment	Self assessed pain according to NRS (numeric rating scale)	60 minutes

Secondary Outcomes

Measure	Description	Time Frame
Pain relief medication	Between-group comparison of analgesia provided by nursing staff up to 24 hours after presentation at ER.	24 hours from enrollment.
Negative impact on radiology	Splint artefacts on radiological exam.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

NRS 5-10
Suspected distal fracture of radius

Exclusion Criteria:

No X-ray veriefied fracture.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emergency department, Malmö university hospital	Recruiting	Malmö		20502	Sweden

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All IDP collected will be shared upon request.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014954	Wrist Injuries
D000092503	Wrist Fractures
D059787	Acute Pain

Ancestor Terms

ID	Term
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided