| CTRI Number |
CTRI/2021/06/034410 [Registered on: 28/06/2021] Trial Registered Prospectively |
| Last Modified On: |
25/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“ Analysis Of various Factors Causing Early Revision surgery In Patients Undergoing Degenerative Lumbar Spine Surgery - A Single Centre Study†|
|
Scientific Title of Study
|
“Critical Analysis Of Factors Causing Early Re Exploration In Patients Undergoing Degenerative Lumbar Spine Surgery - A Single Centre Study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karthik Ramachandran |
| Designation |
Doctor |
| Affiliation |
Ganga Hospital |
| Address |
Department of orthopaedics/ Spine surgery division
313, Mettupalayam road, Coimbatore-641043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9791594514 |
| Fax |
|
| Email |
karthik.dr.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Karthik Ramachandran |
| Designation |
Doctor |
| Affiliation |
Ganga Hospital |
| Address |
Department of orthopaedics/ Spine surgery division/ Ganga Hospital,313, Mettupalayam road
Coimbatore-641043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9791594514 |
| Fax |
|
| Email |
karthik.dr.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karthik Ramachandran |
| Designation |
Doctor |
| Affiliation |
Ganga Hospital |
| Address |
Department of orthopedics, Spine surgery division, Ganga Hospital
313, Mettupalayam road
Coimbatore-641043
Coimbatore
TAMIL NADU
641043
India |
| Phone |
9791594514 |
| Fax |
|
| Email |
karthik.dr.r@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ganga Hospital |
| Address |
313, Mettupalayam Road
Coimbatore-641043 |
| 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 |
| Karthik R |
Ganga Hospital |
Department of orthopaedics/ Spine surgery division/
313, Mettupalayam road
coimbatore-641043
Coimbatore
TAMIL NADU |
9791594514
karthik.dr.r@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (Ganga Hospital ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M478||Other spondylosis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients were included if one or more of the following symptoms:
Persistent / new onset radicular pain within a week following the surgery.
Muscle strength of their lower limbs had declined by more than two grades after posterior lumbar surgery
|
|
| ExclusionCriteria |
| Details |
Re exploration surgery was needed because of other non-neurogenic factors, i.e., wound exudations, wound infections, or foreign body residues.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| VAS score |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ODI score |
1 week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/06/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To critically analyse factors causing early re exploration in patients undergoing degenerative lumbar spine surgery |