| 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
|
|
|
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
|
|
|
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 |