| CTRI Number |
CTRI/2021/11/038348 [Registered on: 30/11/2021] Trial Registered Prospectively |
| Last Modified On: |
27/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Relevance of 3 dimensional information during pedicle screws fixation using preoperative CT scan and intraoperative images. |
|
Scientific Title of Study
|
Clinical relevance of 3D information in spine surgery for accurate placement of pedicle screws by registering preoperative CT with intraoperative images. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditya Pratap Shah |
| Designation |
Junior Resident , Department Of Orthopaedics |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Room Number 4 , Orthopaedics OPD ,Ground Floor , OPD Building, Kasturba Hospital , Manipal , Udupi, Karnataka .Pin Code 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9717752354 |
| Fax |
|
| Email |
aditya777shah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamasunder Bhat N |
| Designation |
Professor and Head , Department Of Orthopaedics |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Room Number 4, Orthopaedics OPD, Ground Floor, OPD Building, Kasturba Hospital, Manipal , Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9480486075 |
| Fax |
08202571934 |
| Email |
shyambhat.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Pratap Shah |
| Designation |
Junior Resident , Department Of Orthopaedics |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Room Number 4 , Orthopaedics OPD ,Ground Floor , OPD Building, Kasturba Hospital , Manipal , Udupi, Karnataka .Pin Code 576104
KARNATAKA
576104
India |
| Phone |
9717752354 |
| Fax |
|
| Email |
aditya777shah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kastuba Medical College , Manipal |
|
|
Primary Sponsor
|
| Name |
Kastuba Medical College Manipal |
| Address |
Kastuba Medical College , Manipal |
| 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 |
| Aditya Pratap Shah |
Kasturba Medical College , Manipal |
Room number 4 , Ground Floor , OPD Building , Kasturba Hospital Manipal, Udupi, Karnataka , India.
Udupi
KARNATAKA |
9717752354
aditya777shah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College And Kasturba Hospital Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All the adults with single level spinal infection/ Pathology who underwent decompression and fusion using pedicle screws |
|
| ExclusionCriteria |
| Details |
Children
Patients with multiple level involvement.
Decompression and fusion done for other purposes.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Success rate of the procedure while using 3D information during surgeries.
Rate of change of path of screws during the surgery
|
Immediate Post Operatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Success rate of the procedure while using 3D information during surgeries.
|
Nil |
|
|
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)
|
01/12/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Pre operative CT scan will be done for all the patients. 3D to 2D co-relation will be done using segmental based technique developed by the Manipal institute Of Technology for co-relating CT scan images with Intra-operative C Arm fluoroscopy Images giving the surgeon real time 3D information during surgery for accurate placement of pedicle screws. Post surgery Imaging to confirm a) Screw width, b) Screw diameter, c) screw angulation to confirm accuracy. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pre Operative CT scan will be done for all the patients . 3D to 2D correlation will be done using segmental based technique (a software) developed by Manipal Institute of Technology , Manipal. This software will be used to correlate Intra operative C Arm floroscopy images giving the surgeon a realtime 3D information of the patient’s anatomy while doing the surgery |