SynostosisNCT07162233
Surgical Corection of Congenital Proximal Radioulnar Synostosis Using Double Osteotomy Technique.
A study testing derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis in people with Synostosis, run by Sohag University at 1 site in Egypt.
Trial summary
The purpose of the present study is to asses and maintain derotation osteotomy for treating proximal radioulnar synostosis. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Synostosis
- What is being tested?
- derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with congenital idiopathic proximal radioulnar synostosis at the age of 4:12 years old.
Who cannot join
- patients with post traumatic proximal radioulnar synostosis, patients with distal ra-dioulnar synostosis and patients with neuromuscular disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
mohammed refat mohammed Refaat Mohammed Hassan contact
About this study
Official title: Assessment and Maintenance of Derotation Osteotomy Utilizing Kirschner Wires for the Correction of Congenital Proximal Radioulnar Synostosis
The purpose of the present study is to asses and maintain derotation osteotomy for treating proximal radioulnar synostosis.
Read the 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.
- Conditions
- Synostosis
- Being tested
- derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis
- Medical subject headings
- Synostosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosisProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SynostosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The aim of the work is to asses and maintain derotation osteotomy for treating proximal radioulnar synostosis.
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Refaat Mohamed Hassan, Sohag University
- Investigators
- Marwan shams eldeen, MD orthopedeic, Study chair, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162233
- Sponsor's protocol ID
- Soh-Med--25-8-4MS
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Maintenance of Derotation Osteotomy Utilizing Kirschner Wires for the Correction of Congenital Proximal Radioulnar Synostosis
- ClinicalTrials.gov ID
- NCT07162233
- Acronym / sponsor ID
- Soh-Med--25-8-4MS
- Conditions
- Synostosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The aim of the work is to asses and maintain derotation osteotomy for treating proximal radioulnar synostosis.
| Arm | Type | Receives |
|---|---|---|
| child 4 : 12 age with congenital radioulnar synostosis | Experimental | Procedure: derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosisAssessment and maintenance of derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with congenital idiopathic proximal radioulnar synostosis at the age of 4:12 years old.
Key exclusion criteria (1 listed)
- patients with post traumatic proximal radioulnar synostosis, patients with distal ra-dioulnar synostosis and patients with neuromuscular disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosisThe 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 | Procedure or surgery | child 4 : 12 age with congenital radioulnar synostosis |
Primary outcome
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 .
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
mohammed refat mohammed Refaat Mohammed Hassan contact
Marwan shams eldeen, MD orthopedeic study chair
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis in people with Synostosis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact mohammed refat mohammed Refaat Mohammed Hassan (+201010670744, mohamed_refaat_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical derotation osteotomy utilizing Kirschner wires for the correction of congenital proximal radioulnar synostosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.