Assiut University Hospital
Asyut, Asyut Governorate, 71511, Egypt
NCT Number: NCT07429656
The primary objective of this study is to evaluate the early results of Active Apex Correction (APC) technique for managing early onset scoliosis.
Trial opening soon.
Get NotifiedUp to 10 year
All sexes
Interventional
Not applicable
Asyut, Asyut Governorate, 71511, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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 (%).
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.
Time frame: one year postoperative
All complications (infection, implant failure, neurological deficit, wound issues) within one year postoperative will be recorded.
Contact information is provided by the study sponsor or research team.
Assiut University
Other
Acronym: APC-EOS
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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.
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