Surgical Corection of Congenital Proximal Radioulnar Synostosis Using Double Osteotomy Technique.
Assessment and Maintenance of Derotation Osteotomy Utilizing Kirschner Wires for the Correction of Congenital Proximal Radioulnar Synostosis
1 other identifier
interventional
1
1 country
1
Brief Summary
The purpose of the present study is to asses and maintain derotation osteotomy for treating proximal radioulnar synostosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2025
Shorter than P25 for not_applicable
1 active site
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
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedFirst Posted
Study publicly available on registry
September 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedSeptember 9, 2025
August 1, 2025
4 months
August 30, 2025
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
EXPERIMENTALAssessment and maintenance of 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
Eligibility Criteria
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
- Sohag Universitylead
Study Sites (1)
Sohag Faculty of medicine
Sohag, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marwan shams eldeen, MD orthopedeic
Sohag University
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
- 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