- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07727408
Management of Early Onset Scoliosis by Active Apex Correction Technique
July 23, 2026 updated by: Mahmoud Gaber Elsayed, Al-Azhar University
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: mahmoud gaber
- Phone Number: +201094189506
- Email: mahmoudgaber300@gmail.com
Study Locations
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypt, 71524
- Recruiting
- Al-Azhar University Hospital, Assiut
-
Contact:
- Khaled Abd El-Azeem Eed
- Phone Number: 01116446711
- Email: Khalidabdelazeem.622@azhar.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- patients with early-onset scoliosis below 10 years
- patients not operated on before.
Exclusion Criteria:
- Patients above 10 years.
- Patients operated on before
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline to 12 months after Active Apex Correction (APC) surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in thoracic spinal growth
Time Frame: Baseline to 12 months
|
Change in T1-T12 spinal height (mm) measured on standing whole-spine radiographs.
|
Baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 25, 2023
Primary Completion (Estimated)
October 11, 2026
Study Completion (Estimated)
January 2, 2027
Study Registration Dates
First Submitted
November 19, 2023
First Submitted That Met QC Criteria
July 23, 2026
First Posted (Actual)
July 27, 2026
Study Record Updates
Last Update Posted (Actual)
July 27, 2026
Last Update Submitted That Met QC Criteria
July 23, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- MEOSAPCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Contact through my phone number or my email
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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Clinical Trials on Active Apex correction of scoliotic deformity
-
Assiut UniversityNot yet recruitingEarly Onset Scoliosis (EOS)Egypt
-
Istituto Ortopedico RizzoliCompleted
-
AO Foundation, AO SpineScoliosis Research SocietyCompletedAdult Spinal DeformityUnited States, Spain, Denmark, China, United Kingdom, Canada, Japan
-
ApifixWithdrawnAdolescent Idiopathic Scoliosis
-
Cairo UniversityCompleted
-
Atlas UniversityCompleted