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临床试验/NCT06500195
NCT06500195已完成不适用

Cobb Angle Comparison of Hybrid Construct Versus Pedicle Screw-only System for the Treatment of Lenke 1 Adolescent Idiopathic Scoliosis

Pomeranian Medical University Szczecin1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
correction efficacy

研究概览

简要总结

The placement of pedicular screws in spinal surgery has become the gold standard for scoliosis treatment. However, the use of sublaminar bands (SBs) on the apex of the curvature in idiopathic scoliosis (AIS) lowers the risk of neurological complications related to incorrect implementation of transpedicular screws into dysplastic pedicles without a cancellous channel. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used.

详细描述

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformation of the spine. The goal of the treatment is to achieve a reduction in deformity, restoring proper alignment and the best possible function of the spine. Pedicular screw placement in spinal surgery has become the gold standard for scoliosis reduction techniques in the last 30 years [6]. The screw-only systems are relatively safe, as various authors have proven. However, if implemented incorrectly, the screws increase the risk of damage to nervous or vascular structures and internal organs. The latest research does not define a set of anatomical guidelines for applying SBs, nor does it use a dedicated classification system related to the structure of pedicles. The aim of this study was to assess the safety of the method and the correction attained through hypoplastic/aplastic pedicles when applying a hybrid instrumentation system to patients suffering from AIS Lenke type 1. Methods: Twenty patients were involved in a prospective, single-center, non-randomized case series study. The patients were assigned to the group "SCREWS" or "HYBRID" where SBs were used. The inclusion criteria were this being the patients' first scoliosis operation due to AIS (Lenke type 1) and age under 18 years. The primary measured outcome involved correction efficacy, defined as the Cobb score baseline to endpoint change.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • idiopathic scoliosis (AIS)
  • Lenke type 1

排除标准

  • AIS other than Lenke type 1 (neurogenic, congenial, or syndromic curvatures)
  • abnormalities in the structure of the central nervous system in the MRI image
  • advanced chronic respiratory or circulatory failure
  • emergency surgery
  • reoperation

结局指标

主要结局

correction efficacy

时间窗: at the 3rd day after the surgery procedure

defined as the Cobb score baseline to endpoint change (Cobb angle change in the operated spine segment in % at endpoint: X-ray imaging was performed (AP and lateral)

次要结局

  • length of surgery procedure(procedure (from skin incision to skin suture))

研究者

发起方
Pomeranian Medical University Szczecin
申办方类型
Other
责任方
Sponsor

研究点 (1)

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