| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M480||Spinal stenosis, |
|
|
Intervention / Comparator Agent
|
|
|
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. |