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临床试验/NCT07429656
NCT07429656尚未招募不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
试验地点
1
主要终点
Spinal Length Correction (T1-T12 and T1-S1) in millimeters.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

Early onset scoliosis (EOS) patients

Experimental

Early onset scoliosis (EOS) Any scoliosis starting before the age of 10 years including congenital, neuromuscular, syndromic, and idiopathic types.

干预措施: Active Apex Correction (APC) (Procedure)

结局指标

主要结局

Spinal Length Correction (T1-T12 and T1-S1) in millimeters.

时间窗: 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.

次要结局

  • Percentage of correction of the primary curve (%).(one year postoperative)
  • Thoracic Kyphosis Angle (Cobb Method) in degrees(one year postoperative)
  • Number of Participants with Postoperative Complications.(one year postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Youssef Sameh

Assisstant Lecturer

Assiut University

研究点 (1)

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