| CTRI Number |
CTRI/2022/02/040128 [Registered on: 09/02/2022] Trial Registered Prospectively |
| Last Modified On: |
13/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
Comparative analysis of bare window in Spinal fusion surgeries in age related lumbar deformities. |
|
Scientific Title of Study
|
Comparative morphometric analysis of bare window in oblique lumbar
interbody fusion in degenerative lumbar scoliosis. |
| Trial Acronym |
Bare OLIF |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrDDevanand |
| Designation |
Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 Ahmadabad GUJARAT 380006 India |
| Phone |
09925248584 |
| Fax |
07926408174 |
| Email |
drdanand@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
DrDDevanand |
| Designation |
Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006
GUJARAT 380006 India |
| Phone |
09925248584 |
| Fax |
07926408174 |
| Email |
drdanand@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
DrDDevanand |
| Designation |
Spine Surgeon |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006
GUJARAT 380006 India |
| Phone |
09925248584 |
| Fax |
07926408174 |
| Email |
drdanand@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 |
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine hospital & 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 |
| DrDDevanand |
Stavya Spine Hospital & Research Institute |
No. 9, 2nd floor Annexe
Stavya Spine hospital & Research Institute
Ellisbridge, Mithakhali
Ahmedabad 380006 Ahmadabad GUJARAT |
7874444091 07926408174 drdanand@yahoo.co.in |
|
|
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: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
1.Cobbs angle measured from L1 superior end plate to S1 superior end plate in anteroposterior radiographs
2.Angle <10 degree will be included in N Group, >10 degree with left sided convexity than included in L group and >10 degree with right sided convexity than included in D group
|
|
| ExclusionCriteria |
| Details |
• T2W axial images were analysed and images that were not parallel to the end-plate
• Patient not fulfilling inclusion criteria
• Patients with infection, trauma, tumours, idiopathic scoliosis, old operated for lumbar spine and/or history of retroperitoneal surgeries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in lumbar curvature in lumbar degenerative scoliosis leads to changes in bare window for OLIF. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in lumbar curvature in lumbar degenerative scoliosis leads to changes in bare window for OLIF. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/02/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Lumbar interbody fusion (LIF) is a
treatment strategy for various spinal disorders, including unstable
degenerative conditions not limited to trauma, infection and neoplasia. An LIF
can be achieved via posterior approaches, transforaminal interbody Fusion
[TLIF] and posterior lumbar interbody fusion [PLIF], and the anterolateral
approaches, anterior lumbar interbody Fusion [ALIF], transpsoas lateral lumbar
interbody Fusion [LLIF] and oblique lumbar interbody Fusion [OLIF]. Posterior
approaches disrupt the posterior tension band, cause iatrogenic injury to
paraspinal musculature, and have limited endplate exposure restricted by thecal
sac and nerve roots, which may cause difficulty in correcting coronal imbalance
and lordosis restoration.
The indications of OLIF have
expanded overtime to include a wide spectrum of degenerative disorders from
single level lumbar pathology to multilevel adult degenerative scoliosis (ADS).
Large sized spacers are thought to be effective in restoring sagittal and
coronal balance of patients in ADS. For a spine surgeon, clear understanding of
the local anatomical features and surgical corridors help in achieving a good
outcome. The Objectives of the study are :
To measure OLIF operative windows from L2–L3 to L4–L5
level in normal patients and patients with ADS.
To assess various anatomical changes that determine the
feasibility of OLIF technique following MRI based morphometric evaluation in
ADS |