NCT06542471

Brief Summary

A randomized controlled trial to compare between dual intramedullary nailing and dual plating trying to synthesis a high quality evidence study that can solve the conflict between the decisions.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress85%
Aug 2024Sep 2026

First Submitted

Initial submission to the registry

July 6, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

August 7, 2024

Status Verified

June 1, 2024

Enrollment Period

2 years

First QC Date

July 6, 2024

Last Update Submit

August 3, 2024

Conditions

Intramedullary NailPlate FixationForearm FractureRandomized Controlled Trial

Keywords

forearm fracturespediatric fracturesflexible nailplate fixation

Outcome Measures

Primary Outcomes (4)

  • Time to union

    weeks required to achieve union

    6 months

  • Elbow range of motion

    elbow flexion, extension, pronation and supination in degrees

    6 months

  • Quick DASH score

    Patient reported questionnaire

    6 months

  • patient satisfaction questionnaire

    five points Likert scale

    6 months

Secondary Outcomes (4)

  • Adverse events

    6 months

  • Re-operation rate

    6 months

  • size of wound scar in millimeters

    6 months

  • Deformity (malunion rate)

    6 months

Study Arms (2)

group 1

EXPERIMENTAL

Intramedullary nail group

Device: Dual intramedullary nailing

group 2

EXPERIMENTAL

Plating group

Device: Dual plating

Interventions

Dual intramedullary nailingDEVICE

\- Elastic nailing for radius under image guidance through distal entry point and physeal sparing technique.

group 1
Dual platingDEVICE

\- ORIF for radius done first through volar approach.

group 2

Eligibility Criteria

Age9 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Both-bone Forearm Diaphyseal Fracture.
  • age more than or equal nine years old with open distal radius physis.
  • Simple transverse or short oblique fractures (2R2-A2,2R2-A3,2U2-A2,2U2-A3) according to OTA/ AO classification.

You may not qualify if:

  • Neurovascular injury.
  • Open fractures
  • Comminuted fractures
  • Pathological fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University

Cairo, 11655, Egypt

Location

Study Officials

  • Mahmoud Mahran, MD

    Ain Shams University

    STUDY CHAIR

  • Ahmed Saeed Younis

    Ain Shams University

    STUDY DIRECTOR

  • Abdelrahman Hani

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2024

First Posted

August 7, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

August 7, 2024

Record last verified: 2024-06

Locations

EG(1)