Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07429656

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

The primary objective of this study is to evaluate the early results of Active Apex Correction (APC) technique for managing early onset scoliosis.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

Up to 10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Apex Correction (APC)

Procedure
  • 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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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 (%).

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Youssef Sameh Yassin Francis

CONTACT

[email protected]

+201289641423

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Acronym: APC-EOS

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Feb 24, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.