Active Apex Correction (APC) for Early Onset Scoliosis. Early Results of a Pilot Study. (APC-EOS)

February 23, 2026 updated by: Youssef Sameh, Assiut University
The primary objective of this study is to evaluate the early results of Active Apex Correction (APC) technique for managing early onset scoliosis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Early onset scoliosis (EOS) presents a significant clinical challenge due to progressive spinal deformity during critical periods of spinal and thoracic growth. Inadequate management may result in thoracic insufficiency, impaired pulmonary development, and long-term cardiopulmonary morbidity. Achieving deformity control while preserving spinal growth remains the primary treatment goal.

Conservative strategies such as bracing and serial casting may delay progression but are often insufficient, necessitating surgical intervention.Early definitive spinal fusion arrests spinal growth and causes truncal shortening.

Growth-friendly, non-fusion techniques preserve spinal growth while controlling deformity. Traditional growing rods (TGR) require repeated surgical lengthening, resulting in high complication risks including infection, implant failure, and unplanned reoperations. Repeated distractions may lead to unintended spinal autofusion, compromising growth potential. Magnetically controlled growing rods reduce repeated surgeries but remain costly with mechanical failure risks. The Shilla system allows spinal growth but faces loss of correction and implant failure.

Active Apex Correction (APC) is a relatively novel growth-friendly surgical technique, first innovated approximately 16 years ago, gaining increasing international interest recently. APC, a Shilla modification, addresses limitations of existing growth-preserving strategies. APC employs a single surgical procedure with unilateral convex-side compression at the curve apex, allowing guided spinal growth while avoiding concave-side instrumentation, osteotomies, and repeated lengthening procedures. This approach may reduce operative time, implant density, infection risk, and treatment cost. However, despite theoretical advantages, clinical data on APC remain limited. Therefore, evaluating radiographic correction, growth preservation, and clinical outcomes with APC is necessary to define its role in managing EOS.

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

Study Locations

  • Egypt
    • Asyut Governorate
      • Asyut, Asyut Governorate, Egypt, 71511

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

No

Description

Inclusion Criteria:

  • All patients with progressive early onset scoliosis (congenital, idiopathic, neuromuscular or syndromic).
  • Major curve Cobb angle ≥ 40°
  • Child below 10 years of age or less than Risser grade 2
  • No prior scoliosis surgery

Exclusion Criteria:

  • Age above 10 years or more than Risser grade 2.
  • Operated EOS cases indicated for revision.
  • Active infection or systemic illness precluding surgery.

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: Early onset scoliosis (EOS) patients
Early onset scoliosis (EOS) Any scoliosis starting before the age of 10 years including congenital, neuromuscular, syndromic, and idiopathic types.
Procedure: Active Apex Correction (APC)
• Active Apex Correction (APC) begins with the identification of the curve apex and the selection of upper and lower "foundation" vertebrae, where pedicle screws are placed on the convex side only, above and below the most wedged vertebrae. No screws are inserted on the concave side, avoiding the need for osteotomies at the apex. The rods are then connected to both upper and lower foundation constructs, contoured to maintain appropriate sagittal alignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spinal Length Correction (T1-T12 and T1-S1) in millimeters.
Time Frame: At latest follow-up (1 year postoperative)
Spinal length will be assessed on standing full-spine radiographs at the latest postoperative follow-up. Measurements will include the distance from T1 to T12 and from T1 to S1 in millimeters.
At latest follow-up (1 year postoperative)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of correction of the primary curve (%).
Time Frame: one year postoperative
The Cobb angle of the primary scoliotic curve will be measured on preoperative and latest postoperative standing radiographs. The correction will be calculated in Percentage (%).
one year postoperative
Thoracic Kyphosis Angle (Cobb Method) in degrees
Time Frame: one year postoperative
Thoracic kyphosis will be measured on lateral standing radiographs between T1 and T12 using the Cobb angle method. The angle will be recorded in degrees (°) at the latest postoperative follow-up.
one year postoperative
Number of Participants with Postoperative Complications.
Time Frame: one year postoperative
All complications (infection, implant failure, neurological deficit, wound issues) within one year postoperative will be recorded.
one year postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

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.

General Publications

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 (Estimated)

March 1, 2026

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APC for EOS

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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