NCT07162233

Brief Summary

The purpose of the present study is to asses and maintain derotation osteotomy for treating proximal radioulnar synostosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

September 9, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

August 30, 2025

Last Update Submit

September 5, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • surgical derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis

    Proximal radio-ulnar synostosis is a skeletal malformation of the upper limb characterized by bony fusion at the proximal aspect of the radius and ulna. The proximal third is considered the most common site of the radio-ulnar synostosis. This deformity is found mainly in preschool-aged children (4:8 years old), The proximal radioulnar synostosis was first described by the Dutch anatomist Eduard Sandifort in 1793¹. The ideal treatment for congenital radioulnar synostosis aims to restore rotational function and prevents the recurrence of the bony bridges. we aim to do surgical osteotomy and correct the synostosis to restore the function of the upper limb and will be assessed by geniometry , clinical and functional outcomes .

    one year

Study Arms (1)

child 4 : 12 age with congenital radioulnar synostosis

EXPERIMENTAL

Assessment and maintenance of derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis

Procedure: derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis

Interventions

The level of distal radial and proximal ulnar osteotomies is determined under C- arm. A k-wire is inserted in the outer border of the metaphysis of the radius distal to the level of the osteotomy, engaging and transfixing the radioulnar joint, small skin incision is made over the dorsal aspect of the forearm at the level of distal radial osteotomy, dissection of subcutaneous tissue with good exposure of the extensor tendons, transverse osteotomy is done using 2.5 mm drill bit and small sharp osteotme, allowing derotation movement of the distal part of the radius using the k-wire. Another small skin incision is made over the level of proximal ulnar osteotomy, dissection of subcutaneous tissue, another ulnar transverse osteotomy is done distal to the level of the proximal radioulnar synostosis. Derotaion of the forearm is adjusted in the functional position of the forearm in around (10˚:20˚supination), wound closure using absorbable Vicryl sutures. Above elbow cast is used f

child 4 : 12 age with congenital radioulnar synostosis

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients with congenital idiopathic proximal radioulnar synostosis at the age of 4:12 years old.

You may not qualify if:

  • patients with post traumatic proximal radioulnar synostosis, patients with distal ra-dioulnar synostosis and patients with neuromuscular disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

Synostosis

Condition Hierarchy (Ancestors)

DysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marwan shams eldeen, MD orthopedeic

    Sohag University

    STUDY CHAIR

Central Study Contacts

mohammed refat mohammed Refaat Mohammed Hassan

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The aim of the work is to asses and maintain derotation osteotomy for treating proximal radioulnar synostosis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment and maintenance of derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis

Study Record Dates

First Submitted

August 30, 2025

First Posted

September 9, 2025

Study Start

September 1, 2025

Primary Completion

January 1, 2026

Study Completion

April 1, 2026

Last Updated

September 9, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations