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CTRI Number  CTRI/2024/04/065665 [Registered on: 15/04/2024] Trial Registered Prospectively
Last Modified On: 05/04/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Parameters of disc disease of spine 
Scientific Title of Study   Sagittal balance and Spinopelvic parameters as related to Intervertebral lumbar disc degeneration and Lumbar canal stenosis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kashyap Kanani 
Designation  Senior Rsident 
Affiliation  Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha 
Address  305,Aditya Residency, Senior Resident, Department of Orthopaedics, Jawaharlal Nehru Medical College,Sawangi Meghe, Wardha, Maharashtra, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9428888904  
Fax    
Email  kashyap.kanani.16@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ratnakar Ambade 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Orthopaedics department, Jawaharlal Nehru Medical college, Sawangi(Meghe), Wardha, MAHARASHTRA 442001 India

Wardha
MAHARASHTRA
442001
India 
Phone  9823033511  
Fax    
Email  drambade@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Kashyap Kanani 
Designation  Senior Resident 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  305,Aditya Residency, Senior Resident, Department of Orthopaedics, Jawaharlal Nehru Medical College,Sawangi Meghe, Wardha, Maharashtra, 442001

Wardha
MAHARASHTRA
442001
India 
Phone  9428888904  
Fax    
Email  kashyap.kanani.16@gmail.com  
 
Source of Monetary or Material Support  
Department of Orthopaedics ,Jawaharlal Nehru Medical College (JNMC) , Sawangi ( Meghe ) , Wardha, Maharashtra, India 442001 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College 
Address  Department of Orthopaedics ,Sawangi(Meghe) ,Wardha , Maharashtra Wardha MAHARASHTRA, India 442001 
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 Kashyap Kanani  Jawaharlal Nehru Medical College  Department of Orthopaedics ,Sawangi(Meghe) ,Wardha , Maharashtra Wardha MAHARASHTRA, India 442001
Wardha
MAHARASHTRA 
9428888904

kashyap.kanani.16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DATTA MEGHE INSTITUTE OF HIGHER EDUCTION AND RESEARCH INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M480||Spinal stenosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  All the patients with low back pain and/or leg pain with neurological claudication. 
 
ExclusionCriteria 
Details  1) History of previous lumbar spine surgery, trauma, sacral tumours, infection, metastasis and congenital spinal anomalies and scoliosis.
2) Coxo-femoral pathology.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pelvic incidence, Sacral slope, Pelvic tilt,Lumbar lordosis, Sacral inclination, Lumbosacral angle (LSA), Sacrofemoral distance, Disc degeneration assessment using T2-weighted sagittal images.
Lumbar canal diameter will be measured on axial T2-weighted MRI images. 
Parameters will be assessed at the baseline only. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
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)   19/04/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The relationship between sagittal balance, spinopelvic parameters, and various spinal pathologies such as intervertebral lumbar disc degeneration (IDD) and lumbar canal stenosis (LCS) has been a subject of significant interest and research within the field of orthopedics and spinal medicine. Understanding the intricate interplay between the anatomical alignment of the spine, the pelvis, and the occurrence of degenerative spinal conditions is crucial for both diagnosis and treatment planning (1).

Sagittal Balance: Sagittal balance refers to the alignment of the spine in the sagittal plane, which is the plane that divides the body into left and right halves. It involves the assessment of the spinal curvature and its relationship to the pelvis and lower extremities (2). Maintaining proper sagittal balance is essential for the spine to function optimally and to distribute loads evenly throughout the vertebral column. Imbalances in the sagittal plane can lead to abnormal stress on spinal structures, potentially contributing to the development of degenerative conditions (3).

Spinopelvic Parameters: Spinopelvic parameters encompass a set of anatomical measurements that describe the relationship between the spine and the pelvis. These parameters include pelvic incidence (PI), pelvic tilt (PT), and sacral slope (SS). These measurements are crucial in evaluating the overall alignment of the spine and pelvis, providing valuable insights into the biomechanics of the lumbar spine. Changes in spinopelvic parameters can influence spinal balance and may be associated with degenerative processes in the lumbar region (4).

Intervertebral Lumbar Disc Degeneration (IDD): Intervertebral lumbar disc degeneration is a common age-related condition characterized by the breakdown of the intervertebral discs located between the vertebrae of the lumbar spine. As the discs degenerate, they lose their ability to absorb shock and provide flexibility to the spine (5). The relationship between sagittal balance, spinopelvic parameters, and IDD is an area of interest, as abnormal spinal alignment may contribute to increased mechanical stress on the intervertebral discs.

Lumbar Canal Stenosis (LCS): Lumbar canal stenosis involves the narrowing of the spinal canal in the lumbar region, often leading to compression of the spinal cord and nerve roots (6). Changes in sagittal balance and spinopelvic parameters may impact the biomechanics of the lumbar spine, potentially influencing the development or progression of lumbar canal stenosis.

Research in this field aims to identify correlations between sagittal balance, spinopelvic parameters, and the occurrence of intervertebral lumbar disc degeneration and lumbar canal stenosis. By understanding these relationships, clinicians can better tailor treatment strategies, which may include conservative measures, surgical interventions, or preventive measures to maintain spinal health and function.
 
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