Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT07162233
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Corection of Congenital Proximal Radioulnar Synostosis Using Double Osteotomy Technique.
Sponsor:
Sohag University
Organization:
Study Overview
Official Title:
Assessment and Maintenance of Derotation Osteotomy Utilizing Kirschner Wires for the Correction of Congenital Proximal Radioulnar Synostosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present study is to asses and maintain derotation osteotomy for treating proximal radioulnar synostosis.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: