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CTRI Number  CTRI/2026/01/100861 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective and Prospective 
Study Design  Single Arm Study 
Public Title of Study   Classifications for Congenital Scoliosis 
Scientific Title of Study   Reliability and Prognosis of Various Classifications for Congenital Scoliosis 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr . Salman Sulfeeker  
Designation  Senior Resident, MCh 
Affiliation  Kasturba Medical College ,Manipal .Udupi 
Address  Department of Pediatric Orthopaedics, Kasturba Medical College, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  7034833651  
Fax    
Email  salman.zulficr@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Hitesh Shah 
Designation  Professor and Head Of Department 
Affiliation  Kasturba Medical College ,Manipal , Udupi 
Address  Department of Pediatric Orthopaedics ,Kasturba Medical College ,Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  9036251570  
Fax    
Email  hitesh.Shah@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr. Hitesh Shah 
Designation  Professor and Head Of Department 
Affiliation  Kasturba Medical College , Manipal, Udupi 
Address  Department of Pediatric Orthopaedics, Kasturba Medical College, Manipal, Udupi

Udupi
KARNATAKA
576104
India 
Phone  9036251570  
Fax    
Email  hitesh.Shah@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal, Udupi 
 
Primary Sponsor  
Name  Kasturba Medical College  
Address  Manipal , Udupi , Karnataka 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mohamed Salman Sulfeeker  Kasturba Medical College , Manipl , Udupi  Department of Pediatric Orthopaedics , Kasturba Medical College , Manipl , Udupi
Udupi
KARNATAKA 		 07034833651

salman.zulficr@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Q675||Congenital deformity of spine,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 0 to 18 years with a radiologically confirmed diagnosis of congenital scoliosis.
Availability of adequate radiological imaging, including at least
Standing full-length AP and lateral spine X-rays
3D CT scans (mandatory for prospective cohort; if available for retrospective cases)
MRI spine to evaluate for intraspinal anomalies
Ultrasound abdomen and echocardiography for evaluation of visceral anomalies
Complete clinical records available for retrospective cases (demographics, imaging, follow-up).
For the prospective cohort: Informed consent obtained from parents or legal guardians for participation and radiological evaluation.
 
 
ExclusionCriteria 
Details  Children with scoliosis of non-congenital etiology, including:
Idiopathic scoliosis
Neuromuscular scoliosis
Syndromic scoliosis (e.g., Marfan, Ehlers-Danlos, Neurofibromatosis)
Patients with inadequate or missing imaging or clinical documentation.
Patients lost to follow-up
Patients who have undergone prior spine surgery before initial radiological classification  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Inter-rater Reliability of Congenital Scoliosis Classification Systems  At initial radiological evaluation using available imaging (X-ray ± CT ± MRI)

Same time point for all three rater 
 
Secondary Outcome  
Outcome  TimePoints 
Prognostic Value of Classification Systems  Baseline

6 months

12 months

End of follow-up (maximum available duration) 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="5" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary    
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