| CTRI Number |
CTRI/2025/06/088573 [Registered on: 10/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Satisfaction and functional improvement patients after of spine joining surgery |
|
Scientific Title of Study
|
Satisfaction index after transforaminal lumbar interbody fusion |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Javangula Gowtham |
| Designation |
Junior resident |
| Affiliation |
Department of Orthopedics, Kasturba Medical College, Manipal |
| Address |
Department of Orthopedics, Kasturba Medical College, Manipal
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
7093585523 |
| Fax |
|
| Email |
javangulagowtham116@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrShyamasunder Bhat |
| Designation |
Professor and HOU |
| Affiliation |
KMC Manipal |
| Address |
Department of Orthopedics, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9480486075 |
| Fax |
|
| Email |
shyambhat.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DrShyamasunder Bhat |
| Designation |
Professor and HOU |
| Affiliation |
KMC Manipal |
| Address |
Department of Orthopedics, KMC Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9480486075 |
| Fax |
|
| Email |
shyambhat.n@manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
No funding |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Javangula Gowtham |
Kasturba Hospital, Manipal |
Room No.4, Department of Orthopaedics, OPD block
Udupi
KARNATAKA |
7093585523
javangulagowtham116@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional Ethics Committee- Student Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M48||Other spondylopathies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
All the adult patients treated with single level Transforaminal lumbar interbody fusion at Kasturba hospital, Manipal for spondylolisthesis (Grade 1-3) after failure of conservative management |
|
| ExclusionCriteria |
| Details |
Patients with previous history of spine surgery
Patients with osteoporosis
Elderly population (more than 75yrs)
High grade spondylolisthesis (Grade 4) and spondyloptosis (Grade 5)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Satisfaction index after Transforaminal lumbar inter-body fusion based on the betterment in visual analogue score for pain, North American Spine Society questionnaire, Oswestry disability index |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
01/07/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Patients wil be recruited for the study when they visit the KH, Manipal for follow up(minimum after 1 year) with proper informed consent for participation. Visual analogue score for pain, North American Spine Society questionnaire, Oswestry disability index will be used to evaluate the patient’s satisfaction once during the follow up(minimum 1 year post TLIF).
|