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临床试验/NCT07092917
NCT07092917招募中不适用

Surgical Outcomes and Complications of Posterior Spinal Fusion in Adolescent Idiopathic Scoliosis

Assiut University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
25
试验地点
1
主要终点
clinical evaluation of the patients height thoracic symmetry rib humb

研究概览

简要总结

Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis representing about 80-90% of all idiopathic scoliosis cases , characterized by lateral curvature of the spine of 10 degrees or more in children 10-18 years without underlaying cause .

AIS affects 1-3% of adolescents globally . More common in females with a ratio of 8;1 (1) The exact cause of AIS remain unknown ,however it's thought to be multi factorial may be due to genetic predisposition as it's often familial with multiple genetic loci impacting its pathogenesis heritability range between 30-60% (2) Bio mechanically the asymmetrical growth of the vertebrae and spinal loading may lead to curvature progression during rapid growth spurts Some studies suggest that asymmetrical loading of the spine can progress the deformity.

Multiple risk factors of progression have been detected: younger age at diagnosis , female sex ,higher initial Cobb angle and growth velocity (5) Severe scoliosis causes cosmetic concerns ,height reduction , reduced lung function and may progress to degenerative changes in adulthood (6) Treatment options for AIS include observation , bracing and surgery for curves more than 40 degree Cobb angle (7) Surgical correction has been a controversy for many years depending on the severity of the curve , the facility , surgeons preference and available instrumentation.

Anterior surgery became popular due to some advantage over posterior surgery as direct derotation of the spine ,removal of the disc ,over correction of the apex over short construct but some results from that correction is production of hyper kyphosis which can cause pulmonary problems ,anterior surgery carry high risk of pseudoarthrosis ,increase motion stress distal to corrected levels causing adjacent level disease Anterior surgery also requires high degree of flexibility in curve otherwise it is not applicable .

With advancing technique in posterior surgery and multiple training ,posterior surgery have been widely employed in correction of AIS with the same or even better results in severe cases As there is minimal affection in pulmonary function also it provides correction of Sagittal balance. (8)

详细描述

Adolescent idiopathic scoliosis (AIS) is the most common form of scoliosis representing about 80-90% of all idiopathic scoliosis cases , characterized by lateral curvature of the spine of 10 degrees or more in children 10-18 years without underlaying cause .

AIS affects 1-3% of adolescents globally . More common in females with a ratio of 8;1 (1) The exact cause of AIS remain unknown ,however it's thought to be multi factorial may be due to genetic predisposition as it's often familial with multiple genetic loci impacting its pathogenesis heritability range between 30-60% (2) Bio mechanically the asymmetrical growth of the vertebrae and spinal loading may lead to curvature progression during rapid growth spurts Some studies suggest that asymmetrical loading of the spine can progress the deformity.

Multiple risk factors of progression have been detected: younger age at diagnosis , female sex ,higher initial Cobb angle and growth velocity (5) Severe scoliosis causes cosmetic concerns ,height reduction , reduced lung function and may progress to degenerative changes in adulthood (6) Treatment options for AIS include observation , bracing and surgery for curves more than 40 degree Cobb angle (7) Surgical correction has been a controversy for many years depending on the severity of the curve , the facility , surgeons preference and available instrumentation.

Anterior surgery became popular due to some advantage over posterior surgery as direct derotation of the spine ,removal of the disc ,over correction of the apex over short construct but some results from that correction is production of hyper kyphosis which can cause pulmonary problems ,anterior surgery carry high risk of pseudoarthrosis ,increase motion stress distal to corrected levels causing adjacent level disease Anterior surgery also requires high degree of flexibility in curve otherwise it is not applicable .

With advancing technique in posterior surgery and multiple training ,posterior surgery have been widely employed in correction of AIS with the same or even better results in severe cases As there is minimal affection in pulmonary function also it provides correction of Sagittal balance. (8)

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
8 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • • Male and female Adolescents aged 10 to 18 years diagnosed with AIS
  • Patients with Risser sign 4 and 5 indicating maturity of the skeletal system
  • Patents with lenke classification system 2,3,4
  • Curvature between 40 and 70 degrees Cobb angle indicating moderate to severe scoliosis suitable for surgical correction
  • Candidates for surgical intervention due to rapid progression of deformity more than 5 degrees per year ,functional limitations

排除标准

  • • Congenital or neuromuscular scoliosis
  • Pre operative restrictive lung function
  • Previous spinal surgery
  • Severe co morbidities preventing surgical intervention .

结局指标

主要结局

clinical evaluation of the patients height thoracic symmetry rib humb

时间窗: 2 years

comparison between peoperative and post operative measures of shoulder height , waist symmetry by measures of pelvic tilt .

Cobb angle

时间窗: 2 years

Comparison between pre and post op Cobb angle

functional outcome of patients satisfaction after surgery

时间窗: 2 years

measuring the functional outcome post surgery regarding pain and disability using SRS-22 score , VAS score for pain and Oswestry disability index

次要结局

未报告次要终点

研究者

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

Mohamad Sayed Mohamad

Assistant lecturer af neurosurgery

Assiut University

研究点 (1)

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