DRF Reposition Manual Reduction vs Finger-trap Traction | NCT07697976

Studies
DRF Reposition Manual Reduction vs Finger-trap Traction

NCT07697976

Sponsor

Medical University Innsbruck

Status

Completed

Last Update Posted

Jul 13, 2026Actual

Enrollment

64Actual

Phase

Not Applicable

Conditions

Distal Radius Fractures

Interventions

Finger-trap traction
Manual reduction

Countries

Austria

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

ID	Type	Description	Link
AOTrauma Research Austria 2020	Other Grant/Funding Number	AO Trauma

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Jul 31, 2022Actual

Completion Date

Jul 31, 2022Actual

First Submitted Date

Jun 22, 2026

First Submission Date that Met QC Criteria

Jul 6, 2026

First Posted Date

Jul 13, 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

Jul 6, 2026

Last Update Posted Date

Jul 13, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Participants with distal radius fractures treated conservatively with cast immobilization are assigned to one of two approaches: (1) closed reduction under local anesthesia (hematoma block) followed by traction and casting, or (2) traction and casting without formal reduction. While reduction aims to restore anatomical alignment, loss of reduction may occur during follow-up. The study evaluates whether reduction under local anesthesia provides any benefit over traction alone. The hypothesis is that both treatments result in comparable radiographic alignment and functional outcomes at the end of treatment.

Detailed Description

Participants have sustained a distal radius fracture treated with cast immobilization. Two common conservative management approaches are being compared: (1) closed reduction under a local anesthetic (hematoma block) followed by traction and casting, and (2) immobilization after traction alone without formal reduction under anesthesia.

While the first method aims to restore anatomical alignment initially, loss of reduction may occur over time. The second method improves alignment but does not attempt full anatomical reduction.

The study hypothesis is that both approaches result in similar wrist alignment and functional outcomes after completion of treatment. The objective of this study is to determine whether reduction under local anesthesia followed by traction provides any advantage over traction alone in patients with distal radius fractures.

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

64Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
R: Manual Reduction	Active Comparator		Procedure: Manual reduction
A: Finger-trap traction	Experimental		Procedure: Finger-trap traction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Finger-trap traction	Procedure	15 minutes finger-trap traction only and then cast application	A: Finger-trap traction

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain difference between the groups	Comparison of the pain score in the course of the follow ups between the groups. 0= no pain 10 = worst pain (maximal pain)	From enrollment (Baseline) to the 12month Follow Up.

Secondary Outcomes

Measure	Description	Time Frame
MHQ Hand Score (Patient reported outcome)	Difference in functional outcome measured with MHQ (Michigan Hand Outcome Questionaire) between the two groups. 0 points= very poor hand function / maximum impairment; 100 points → optimal hand function, no impairment.	Enrollment until 12 month follow up
PRWE - Patient reported outcome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Dorsally tilted distal radius fracture (DRF) > 10° (intra-articular or extra-articular) Dorsal comminution of the distal radius fracture

Fracture classification (AO), dorsally displaced:

Exclusion Criteria:

Age under 18 years
Non-displaced fractures of the radius
Previous palmar displaced fractures of the radius
Displacement greater than one shaft width
Open fractures of the radius
Bilateral radius fractures
History of a previous radius fracture
Inability to provide informed consent due to physical or mental disability
Unavailability for follow-up examinations (e.g., abroad, polytrauma)
Lack of full legal capacity
Alcohol or drug abuse
Allergy to local anesthetics
Median nerve irritation
Pregnancy

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

Facility	Status	City	State	ZIP	Country	Contacts
Univ.-Klinik für Orthopädie und Traumatologie		Innsbruck	Tyrol	6020	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000092503	Wrist Fractures
D011885	Radius Fractures
D000071442	Taxis Response

Ancestor Terms

ID	Term
D014954	Wrist Injuries
D001134	Arm Injuries
D014947	Wounds and Injuries
D050723	Fractures, Bone

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