| CTRI Number |
CTRI/2024/01/061238 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Radiological investigation of lumbar lordosis after single level MIS TLIF :Prebent rods ideal or not |
|
Scientific Title of Study
|
Are prebent rods ideal: a radiological analysis of lumbar lordosis after single level MIS TLIF at L3-4, L4-5, and L5-S1 |
| 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 Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Room No 9 2nd floor Annexe Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India
Ahmadabad
GUJARAT
380006
India |
| Phone |
9825019913 |
| Fax |
07926408174 |
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Room No 9 2nd floor Annexe Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India
Ahmadabad
GUJARAT
380006
India |
| Phone |
9825019913 |
| Fax |
07926408174 |
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat R Dave |
| Designation |
Principal Investigator and Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Room No 9 2nd floor Annexe Department-Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmadabad GUJARAT 380006 India
Ahmadabad
GUJARAT
380006
India |
| Phone |
9825019913 |
| Fax |
07926408174 |
| Email |
brd_172@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Room no. 9, second floor Annexe Department Research department Stavya Spine Hospital and
Research Institute Ellisbridge,Mithakhali. |
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmedabad 380006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bharat R Dave |
Stavya Spine Hospital & Research Institute |
Room no. 9, second floor Annexe,Department Research department.
Stavya spine hospital and Research Institute ,Ellisbridge,Mithakhali.Ahmadabad GUJARAT
Ahmadabad
GUJARAT |
9825019913
07926408174
brd_172@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine hospital & Research Institute IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M404||Postural lordosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing a single-level Minimally invasive TLIF procedure for the treatment of a single-level degenerative lumbar condition will be included in the study. |
|
| ExclusionCriteria |
| Details |
Patients undergoing more than one level of surgery
Patients undergoing fusion for a non-degenerative condition(deformity, tumor, trauma or infection)
Patients undergoing fusion for high-grade spondylolisthesis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Lordosis of prebent rod
Total Lumbar Lordosis - pre-operative and post-operative (Day 3)
Segmental Lordosis achieved at the fusion level |
No follow up visit |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
13/01/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
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
|
Fusion surgery increases spine stiffness and
can modify biomechanics and sagittal spinopelvic parameters. Restoration of
sagittal balance is a key issue in lumbar fusion surgery. Inadequate sagittal
plane correction has been associated with adverse postoperative outcomes. Thus
maintainence or restoration of the sagittal plane spinal alignment forms an
important aspect of the lumbar fusion surgery.
An important step of surgical planning
involves the understanding of segmental contributions of different levels in
the sagittal alignment of the spine. Majority of lumbar lordosis is present at
the caudal 2 motion segments. The distribution of the lordosis in the lower (L4-S1)
and upper (L1-L3) arcs is important as it alters the distribution of loads.
Thus, a maldistribution of lordosis may result in mechanical complications in
the post-operative period. |