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CTRI Number  CTRI/2024/09/074329 [Registered on: 25/09/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Measurements of spine and pelvis  
Scientific Title of Study   Association between Sagittal Plane Parameters of Spine and Pelvis and Lumbar Spinal Degeneration 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankit Upadhyay 
Designation  Junior Resident  
Affiliation  Datta Meghe Institute of Higher Education and Research ,Sawangi Meghe, Wardha  
Address  Department of Orthopaedics, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha ,Wardha, Maharashtra

Wardha
MAHARASHTRA
442001
India 
Phone  9920964081  
Fax    
Email  ankitu97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ratnakar Ambade 
Designation  Head of Department 
Affiliation  Datta Meghe Institute of Higher Education and Research ,Sawangi Meghe, Wardha  
Address  Department of Orthopaedics, D Block, Ground Floor , Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha ,Wardha, Maharashtra

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

Wardha
MAHARASHTRA
442001
India 
Phone  9920964081  
Fax    
Email  ankitu97@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College , Datta Meghe Institute of Higher Education and Research, Sawangi Meghe , Wardha, 442001 
 
Primary Sponsor  
Name  Datta Meghe Institute of Higher Education and Research  
Address  Department of Orthopaedics, Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research Sawangi Meghe , Wardha, Maharashtra ,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 Ankit Upadhyay  Jawaharlal Nehru Medical College  Department Orthopaedics, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, Maharashtra ,442001.
Wardha
MAHARASHTRA 
9920964081

ankitu97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DMIHER Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M513||Other thoracic, thoracolumbar andlumbosacral intervertebral disc degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age more than 18 years
Diagnosed case of Lumbar Disc Degenerative Disease
Patients with Spinal radiographs and Pre-operative Lumbar MRI 
 
ExclusionCriteria 
Details  -Patients with Traumatic Spinal Injuries, Spinal Tumors , Spinal Inflammatory Lesions, Spinal Deformities
-Patients with Lower limb Neuromuscular disorders affecting there ability to stand
-Patients with previous surgical intervention at Lumbar spine  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To Ascertain whether there is any correlation between sagittal plane parameters of spine and pelvis and lumbar spinal degeneration   at baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To Ascertain whether there is any correlation between sagittal plane parameters of spine & pelvis on Xray & grade of lumbar spinal degeneration on MRI   at baseline 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   30/09/2024 
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="2"
Months="0"
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   TITLE: Association between Sagittal plane parameters of Spine and Pelvis and Lumbar Spinal Degeneration.

 
INTRODUCTION, RATIONALE: The lumbar spine is the hub of human torso activity. Healthcare providers and patients alike remain frustrated about the causes of postural imbalance, and effective long-term treatment is rendered to recurring estimations. Increasing age, excessive activity, and overloading may cause accelerated aging of the lumbar vertebrae, and external forces may cause secondary pathological changes leading to the rupture of the intervertebral disc annulus fibrous, prolapsed intervertebral disc nucleus pulposus, and lower back pain and neurological dysfunction. Lumbar degenerative diseases include the degeneration of the intervertebral disc, cartilage end plate, vertebral body, and ligaments, of which the degeneration of intervertebral discs is the focus of our attention. Studies have shown that lumbar disc herniation, degenerative lumbar instability, and other degenerative lumbar spinal diseases, such as hyperplasia of articular processes, wedging of vertebral bodies, and hyperosteogeny, are often secondary to disc degeneration. Intervertebral disc degeneration is related to many factors, including spine biomechanics, biology, injury, inflammation, and nutrition. By studying the intervertebral disc, researchers have clarified the pathological changes involved in intervertebral disc degeneration but have ignored the roles of biomechanical factors during its development. A more thorough understanding of the correlations between skeletal alignment parameters should enable clinicians to better understand and treat biomechanical dysfunction in the body. Strong correlations between certain pelvic and spinal positional parameters for a specific patient in an upright posture have been described. Unfortunately, there is still a paucity of information on how common spinal and pelvic parameters correlate and shift through the effect of treatment, yielding little information as to the best-practice method of malalignment treatment. When a person is maintaining a standing position, various parts of the body must be in coordination, forming different spine sagittal patterns and resulting in different biomechanical characteristics. Previous studies have indicated that there are changes in the spinal-pelvic sagittal force lines in patients with spinal deformities and lumbar degenerative diseases to varying degrees. To date, research on whether lumbar intervertebral disc degeneration is related to differences in spinal-pelvic sagittal morphology has been sparse. In this study, correlations of the location, scope, and extent of lumbar intervertebral disc degeneration with sagittal spinal and pelvic parameters will be investigated.

 RESEARCH QUESTION: To ascertain whether there is any correlation between sagittal plane parameters of Spine & Pelvis and Lumbar Spinal Degeneration? 

 AIM: To study the association between sagittal plane parameters of Spine and Pelvis and Lumbar Spinal Degeneration. 

 OBJECTIVES: 
 A. To Study Sagittal plane parameters of Spine on Radiograph 
 B. To Study Sagittal plane parameters of Pelvis on Radiograph 
 C. To Study Lumbar Spinal Degeneration on Magnetic Resonance Imaging scan (MRI) 
 D. To correlate the Sagittal Plane parameters of Spine and Pelvis and Lumbar Spine Degeneration.  

Study Design -Retrospective Cross-sectional Study 

Sample size - 80

Inclusion Criteria 1) Age > 18 years. 2) Diagnosed case of Lumbar Disc Degenerative Disease. 3) Patients with Lateral Spinal Radiographs and pre-operative Lumbar MRI.

Exclusion Criteria: 1) Patients with Spinal Traumatic Injuries, Spinal Tumors, Spinal Inflammatory Lesions, Spinal deformities 2) Patients with Lower Limb Neuromuscular disorders affecting their ability to stand 3) Patients with previous surgical intervention at Lumbar Spine . 

Spinal-pelvic parameters 
(1) Thoracic kyphosis (TK) is the vertebral body with the largest upper thoracic tilt to the junction of the thoracic kyphosis and lumbar lordosis. 
(2) Lumbar lordosis (LL) is the junction of the thoracic kyphosis and lumbar lordosis to the S1 end plate. 
(3) Pelvic incidence (PI) is the angle between the line perpendicular to the S1 end plate from the midpoint of the end plate and the connecting line from the midpoint of the S1 end plate to the center of the femoral head. 
(4) Pelvic tilt (PT) is the angle between the connecting line from the midpoint of the S1 end plate to the centre of the femoral head and the vertical line. (5) Sacral slope (SS) is the angle between the tangent and the horizontal line of the S1 end plate. 
(6) T1 tilt angle (TA) is the angle between the T1 vertebral end plate and the horizontal line.   

Material Methods 
 â— Selection of patient
 â— Radiograph of patient (X-Ray)
 â— Magnetic Resonance Imaging (MRI) 
 â— Measurements of Parameters on Radiograph (X- Ray) 
 â— Correlation of measured Parameters on Radiograph (X-Ray) with Diagnosis and Grading on Magnetic Resonance Imaging (MRI) 
 â— Statistical Analysis of gathered data 
 
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