Surgical Corection of Congenital Proxim… | Clinical Trial

Key information

Conditions

Synostosis Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag Faculty of medicine

Sohag, Egypt

About this study

Proximal radio-ulnar synostosis is a skeletal malformation of the up-per 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.

Congenital proximal radioulnar synostosis is an uncommon genetic malformation of the upper limb.

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.

Although Congenital radio ulnar synostis is an uncommon congenital disease, it is the most common congenital disorder affecting the elbow and forearm joint ,being bilateral in 60-80% of cases .

there is no gold standard option for the treatment of congenital proximal radioulnar synostosis. The ideal treatment for congenital radioulnar synostosis aims to restore rotational function and prevents the recurrence of the bony bridges. Both conservative and surgical treatments are possible, but results are still controversial, the main indication for surgical treatment is the limitation of daily activities. Many surgical methods have been reported aiming restoration of radius rotation around the ulna such as Synostosis resection and artificial bio-logical tissue interposition and derotational osteotomies².

Historically, surgical separation of the synostosis and vascularized and non-vascularized interposition techniques to fill the interosseous space and prevent scar formation and resynostosis had theoretically been considered the ideal treatment³. Nowdays, the leading methods of surgical treatment of Congenital radio ulnar synostosis are precisely the variants of forearm derotation osteotomies such as : gradual correction of pronation deformity using external fixation devices , performing a single-level osteotomy of the radius , osteoto-my of both forearm bones at different levels and osteotomy through the synostosis zone⁴.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Procedure

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

Primary outcomes

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

Time frame: one year

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 .

Study contacts

Contact information is provided by the study sponsor or research team.

mohammed refat mohammed Refaat Mohammed Hassan

CONTACT

[email protected]

+201010670744

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Assessment and Maintenance of Derotation Osteotomy Utilizing Kirschner Wires for the Correction of Congenital Proximal Radioulnar Synostosis

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 9, 2025
Registry last updated: Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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