| CTRI Number |
CTRI/2024/01/061187 [Registered on: 08/01/2024] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Unveiling the Causes of Revision Lumbar Spine Surgery: Insights from a Prospective Observational Cohort Study at a Leading Tertiary Care Spine Institute" |
|
Scientific Title of Study
|
A Prospective Observational Cohort Study
to Analyse the Etiology of Revision Lumbar
Spine Surgery at a Tertiary Care
Spine Institute. |
| 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
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
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: 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 |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
cases previously operated for stenosis, spondylolisthesis, disc prolapse, infections.
cases previously operated by endoscopic spine surgery, MIS spine surgery, open spine
surgery.
cases giving consent for surgery.
Age group 18 and above |
|
| ExclusionCriteria |
| Details |
patients who are not willing to be a part of study.
Age below 18.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This is a study to find the causes of revision surgery hence no outcomes will be measured. |
No scheduling requirements for this study as the study is about causes only |
|
|
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) |
Open to Recruitment |
|
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
|
Low back pain is a highly prevalent condition. About 3 percent of low backache cases need to be treated operatively . Severe back pain and radiating pain or claudicating which are resistant to conservative management are usually selected for surgical management. Due to the increased aging population and the people increasingly getting operated for back ache, the number of revision surgeries are also rising. Early surgical failures might result from insufficient decompression and preoperative lumbar instability, or infection with late recurrence of back or leg problems due to acquired spinal instability or adjacent level degeneration Revision surgery is usually required at the index or adjacent levels. Mostly, revision surgery is required at the index or at adjacent levels. The rates for re operation after decompression without fusion for LSS are rather consistently reported to be around 8–10% 2 to 4 years following surgery. A meta analysis study which reviewed fenestration surgeries showed an average re operation rate of 7.58% ± 5.29% in 8.28 ± 6.26 years follow up as compared to laminectomy alone (12.70% ± 7.49%, 6.50 ± 2.12 years follow up). Laminectomy with or without fusion showed a re operation rate of 11.22% ± 4.25% in 6.00 ± 2.60 years follow up period. The comparative results of these studies were however not significant . While recent studies were able to identify particular factors, such as obesity, smoking, or fusion as decisive for the outcome of lumbar operations, the literature has not demonstrated yet whether these factors influence re operation. Revision lumbar decompression and extension of fixation is the gold standard for fixation.Elderly patients requiring revision lumbar spine surgery are a difficult cohort to treat. Studies have reported poor outcomes when compared to the primary lumbar surgeries. The goal of this study is to identify the various causes of revision at our institute. |