NCT07162142

Brief Summary

Distal radius fractures are the most common fractures in the pediatric population . It accounts for 35% of all pediatric fractures . Although pediatric distal radius fractures can be successfully treated conservatively, reduction losses of 21-39% can be observed in the treatment with a plaster cast . Reduction losses are frequently observed in distal radius diaphyseal metaphyseal junctional (DRDMJ) fractures, primarily due to the limited contact surface of the fracture . There has yet to be a consensus regarding the treatment protocol for DRDMJ fractures . In DRDMJ fractures, surgery is recommended in cases where satisfactory alignment cannot be achieved with closed re-duction and cast immobilization, or there is reduction loss in clinical follow-ups .

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
active not 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 Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2025

Completed
7 months until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 9, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

February 8, 2025

Last Update Submit

August 29, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks

    three months

Study Arms (1)

metaphyseal diaphyseal fracture of distal radial fracture in pediatrics

EXPERIMENTAL
Procedure: elastic nailing with pollar K.wire

Interventions

retrograde elastic nailing of metaphyseal diaphyseal fracture of distal radius in pediatrics

metaphyseal diaphyseal fracture of distal radial fracture in pediatrics

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \- all distal radial fractures in pediatric patients 3-15 years failed closed reduction

You may not qualify if:

  • pathological fracture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdalaziz Youssef Mohammed

Cairo, Egypt

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2025

First Posted

September 9, 2025

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion

December 30, 2025

Last Updated

September 9, 2025

Record last verified: 2025-08

Locations