Menu
Recruiting NCT07092917

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

Observational Asses Radiological Efficacy of Posterior Approach Regarding Correction of Cobb Angle Post Operative . • Asses Scoliosis Idiopathic Adolescent Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Asses Radiological Efficacy of Posterior Approach Regarding Correction of Cobb Angle Post Operative . • Asses, Scoliosis Idiopathic Adolescent Treatment. Basic parameters: 8 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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)

Detailed description

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)

Primary outcome measures

  • clinical evaluation of the patients height thoracic symmetry rib humb [Time frame: 2 years]
  • Cobb angle [Time frame: 2 years]
  • functional outcome of patients satisfaction after surgery [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut university hospitals — Asyut

Identifiers

NCT: NCT07092917 · Scoliosis posterior

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗