| CTRI Number |
CTRI/2024/01/061235 [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
|
Retrospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unveiling the Results of Multiple Revision Surgeries in the Lumbar Spine: A Retrospective Analysis of Outcomes |
|
Scientific Title of Study
|
A retrospective analysis of outcomes in multiple revision surgeries in lumbar spine |
| 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 |
|
| 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
GUJARAT 380006 India |
| Phone |
9825019913 |
| Fax |
|
| 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
GUJARAT 380006 India |
| Phone |
9825019913 |
| Fax |
|
| 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 |
Room no. 9, second floor Annexe,Department Research department. Stavya spine hospital and Research Institute,Ellisbridge,Mithakhali.Ahmadabad GUJARAT |
| 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: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
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 |
All patients who have undergone more than one revision surgery for a degenerative lumbar spine dis-order will be included in the study |
|
| ExclusionCriteria |
| Details |
Patients who do not comply with the inclusion criteria
Patients with inadequate follow up
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cause for revision surgery.
Clinical improvement posts the procedure in terms of VAS and ODI scores.
Complications with revision procedures
|
The patients are followed at least for 2 years post the last surgery
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="385" Sample Size from India="385"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/01/2024 |
| 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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
A few decades ago, spine surgery was only
performed in a few specialized hospitals. These days, there are a lot of
well-trained spine surgeons performing spine procedures. The increase in spine
surgical procedures can be attributed to improvements in diagnostic assessment,
anesthesiological support and surgical instrumentation 1-5. Spine
surgery in general has become a more common, much safer and more efficient
procedure. However, it has also become much more complex. Difficult cases that
were previously advocated to be non-operatively treated have now started to be
treated surgically. This increasing case load has resulted in significant
technical improvements, but also brought about a substantial number of
devastating failures and more complex revision surgeries. The major challenges
for spine surgeons now are to consider patient satisfaction, social costs and
the safety of the surgeries themselves. It was shown that 50% to 90% of the
patients will substantially benefit from the surgery for lumbar spinal stenosis
(LSS)6,7 . However, the outcome tends to deteriorate in the long
term and some of the patients will suffer a certain period after the operation
from return of their previous symptoms8 .In patients having adequate
canal decompression due to spinal stenosis, a restenosis of the spinal canal
can occur. The number of patients requiring reoperation is likely to increase
with time9.
The following study aims to find the amount of
cases undergoing multiple revision surgeries, the cause and outcomes of
multiple revision surgeries and the complications associated with them. |