NCT07697976

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 1, 2018

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
Last Updated

July 13, 2026

Status Verified

June 1, 2026

Enrollment Period

4.5 years

First QC Date

June 22, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

radius fracturefinger-trap tractionmanual reductionclosed reduction

Outcome Measures

Primary Outcomes (1)

  • 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 (6)

  • MHQ Hand Score (Patient reported outcome)

    Enrollment until 12 month follow up

  • PRWE - Patient reported outcome

    Enrollment until 12month follow up

  • Grip strength

    12 weeks until 12mo Follow up

  • Range of motion - functional outcome

    12 weeks until 12 mo follow-up

  • Radiological outcome

    Enrollment until 12 month Follow up

  • +1 more secondary outcomes

Study Arms (2)

R: Manual Reduction

ACTIVE COMPARATOR
Procedure: Manual reduction

A: Finger-trap traction

EXPERIMENTAL
Procedure: Finger-trap traction

Interventions

15 minutes finger-trap traction only and then cast application

A: Finger-trap traction

Hematoma block 5 mL 2% lidocaine, followed by 15 minutes finger-trap traction and then manual reduction + cast application

R: Manual Reduction

Eligibility Criteria

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

You may qualify if:

  • Dorsally tilted distal radius fracture (DRF) \> 10° (intra-articular or extra-articular) Dorsal comminution of the distal radius fracture
  • Fracture classification (AO), dorsally displaced:

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ.-Klinik für Orthopädie und Traumatologie

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Wrist FracturesRadius FracturesTaxis Response

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneForearm InjuriesBehavior, AnimalBehaviorOrientation, SpatialSpatial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2026

First Posted

July 13, 2026

Study Start

February 1, 2018

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

July 13, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations