Cases of Early Onset ScoliosisNCT07727408
Management of Early Onset Scoliosis by Active Apex Correction Technique
A study testing Active Apex correction of scoliotic deformity in people with Cases of Early Onset Scoliosis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Early onset scoliosis is challenging cases in management .different techniques used to correct the deformity ranging between fusionlees and fusion surgery. Fusionless surgery permits developments of vertebral column and lung to avoid thoracic insufficiency syndrome. Read more about this study
- Who is it for?
- Ages 1 year to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cases of Early Onset Scoliosis
- What is being tested?
- Active Apex correction of scoliotic deformity
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Nov 2023to 2 Jan 2027
- 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 1 year to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients with early-onset scoliosis below 10 years
- patients not operated on before.
Who cannot join
- Patients above 10 years.
- Patients operated on before
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Al-Azhar University Hospital, Assiut
Asyut, Asyut Governorate, 71524
Khaled Abd El-Azeem Eed, 01116446711, Khalidabdelazeem.622@azhar.edu.eg
About this study
Early onset scoliosis is challenging cases in management .different techniques used to correct the deformity ranging between fusionlees and fusion surgery. Fusionless surgery permits developments of vertebral column and lung to avoid thoracic insufficiency syndrome. Fusion surgeries for complicated and high curves .New fusionless technique that I will use in my research is to modulate and guide the growth of the Apex of deformity through tethering the convex side and modulate the concave side and follow up the patients to see the results on their radiological and clinical parameters.
- Conditions
- Cases of Early Onset Scoliosis
- Being tested
- Active Apex correction of scoliotic deformity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Apex correction of scoliotic deformityProcedure or surgery
Tethering the convex side of Apex and modulation of the concave side .proximal and distal anchoring screws. Dominos between rods to slide and permits the growth of the vertebral column
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Not described Receives: Procedure: Active Apex correction of scoliotic deformity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in major coronal Cobb angle
Radiographic correction of the primary scoliotic curve measured as the change in the major coronal Cobb angle (degrees) on standing posteroanterior whole-spine radiographs
Measured: Baseline to 12 months after Active Apex Correction (APC) surgery
Secondary outcomes (1)
Change in thoracic spinal growth
Change in T1-T12 spinal height (mm) measured on standing whole-spine radiographs.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start25 Nov 2023
- Primary completion11 Oct 2026 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cases of Early Onset ScoliosisStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Gaber Elsayed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727408
- Sponsor's protocol ID
- MEOSAPCT
- Status last verified
- Jul 2026
- First submitted
- 19 Nov 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Contact through my phone number or my email
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Early Onset Scoliosis by Active Apex Correction Technique
- ClinicalTrials.gov ID
- NCT07727408
- Acronym / sponsor ID
- MEOSAPCT
- Conditions
- Cases of Early Onset Scoliosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 27 Jul 2026 (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.
Early onset scoliosis is challenging cases in management .different techniques used to correct the deformity ranging between fusionlees and fusion surgery. Fusionless surgery permits developments of vertebral column and lung to avoid thoracic insufficiency syndrome. Fusion surgeries for complicated and high curves .New fusionless technique that I will use in my research is to modulate and guide the growth of the Apex of deformity through tethering the convex side and modulate the concave side and follow up the patients to see the results on their radiological and clinical parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Active Apex correction of scoliotic deformity |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients with early-onset scoliosis below 10 years
- patients not operated on before.
Key exclusion criteria (2 listed)
- Patients above 10 years.
- Patients operated on before
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 |
|---|---|---|
| Active Apex correction of scoliotic deformityTethering the convex side of Apex and modulation of the concave side .proximal and distal anchoring screws. Dominos between rods to slide and permits the growth of the vertebral column | Procedure or surgery | Surgery |
Primary outcome
Change in major coronal Cobb angle
Time frame: Baseline to 12 months after Active Apex Correction (APC) surgery
Radiographic correction of the primary scoliotic curve measured as the change in the major coronal Cobb angle (degrees) on standing posteroanterior whole-spine radiographs
1 secondary outcome
Change in thoracic spinal growth
Time frame: Baseline to 12 months
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 27 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Contact through my phone number or my email
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Apex correction of scoliotic deformity in people with Cases of Early Onset Scoliosis, run by Al-Azhar 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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 mahmoud gaber (+201094189506, mahmoudgaber300@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in major coronal Cobb angle (time frame: Baseline to 12 months after Active Apex Correction (APC) surgery). 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 27 Jul 2026.