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Asses Radiological Efficacy of Posterior Approach Regarding Correction of Cobb Angle Post Operative . • AssesScoliosisNCT07092917

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

An observational study of Asses Radiological Efficacy of Posterior Approach Regarding Correction of Cobb Angle Post Operative . • Asses and Scoliosis Idiopathic Adolescent Treatment, run by Assiut University at 1 site in Egypt.

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Trial summary

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 . Read more about this study

Who is it for?
Ages 8 to 21 years
How many people
25 participants
Where
1 siteEgypt
Study dates
15 Apr 2025to 15 Sep 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: 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

Who may be able to join

  • • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site, 1 recruiting
  • Assiut university hospitals

    Asyut, Egypt, 71515

    Mohamad Sayed Waer, masters in neurosurgery, +201066479705, Mohamadswaer@edu.aun.eg

    Recruiting

Other trials in Egypt

About this study

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.

Read more

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)

Read the 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)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07092917
Study groupRoleWhat they receive
posterior fusion surgeryNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. clinical evaluation of the patients height thoracic symmetry rib humb

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

    Measured: 2 years

  2. Cobb angle

    Comparison between pre and post op Cobb angle

    Measured: 2 years

  3. functional outcome of patients satisfaction after surgery

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start15 Apr 2025
  3. Primary completion15 Aug 2027 (estimated)
  4. Study completion15 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07092917
Sponsor's protocol ID
Scoliosis posterior
Acronym
Scoliosis
Status last verified
Jul 2025
First submitted
23 May 2025
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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