| CTRI Number |
CTRI/2021/04/032866 [Registered on: 16/04/2021] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Other |
|
Public Title of Study
|
Study of new technique to insert pedicle screw in cervical spine using advanced technologies (O-arm and Navigation) in Indian subjects |
|
Scientific Title of Study
|
An Investigator Initiated study of Redefining the entry point in insertion of cervical pedicle screw using O arm and Navigation - A prospective radiological study in Indian subjects. |
| Trial Acronym |
CxPS |
|
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 |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor,
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Stavya Spine Hospital & Research Institute Annexe building 2nd floor,
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
9825019913 |
| Fax |
07926408174 |
| Email |
brd_172@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Birju K Vyas |
| Designation |
Chief Physiotherapist |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor,
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Stavya Spine Hospital & Research Institute Annexe building 2nd floor,
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
09925248584 |
| Fax |
07926408174 |
| Email |
birju_spine@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Birju K Vyas |
| Designation |
Chief Physiotherapist |
| Affiliation |
Stavya Spine Hospital And Research Institute |
| Address |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor,
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
Stavya Spine Hospital & Research Institute Annexe building 2nd floor,
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
GUJARAT
380006
India |
| Phone |
09925248584 |
| Fax |
07926408174 |
| Email |
birju_spine@yahoo.com |
|
Source of Monetary or Material Support
Modification(s)
|
| India Medtronic Pvt. Ltd., 1261, Solitaire Corporate Park, Bldg. No. 12, 6th Floor, Andheri - Ghatkopar Link Road, Andheri (East), Mumbai - 400093, India |
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor,
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad |
| 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 |
Stavya Spine Hospital & Research Institute Annexe building 2nd floor,
Near Nagri Hospital, Mithakhali, Ellisbridge
Ahmedabad
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: M95-M95||Other disorders of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. All the patients operated for various cervical pathologies in sub axial level by pos- terior approach using cervical pedicle screws will be included in the study.
2. Age: 18 to 90 Years
3. Psychosocially, mentally and physically able to fully comply with this protocol in- cluding adhering to completing forms and other study procedures.
4. Personally, signed and dated informed consent document prior to any study-related procedures indicating that the patient has been informed of all pertinent aspects of the study.
|
|
| ExclusionCriteria |
| Details |
1. Cervical anterior surgery.
2. Cervical laminectomy without fusion.
3. Lateral mass screw fixation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Single time Evaluation To understand and redefine the entry point, also measure the accuracy of the pedicle screw placement in sub-axial cervical spine using intra-op navigation and O-arm. |
24 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the insertion angle, screw breach using postoperative multi-planar computerized tomography scans.
Radiation dosage and screw insertion time are looked for.
|
24 Months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2021 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
All the patients operated for various cervical pathologies in sub axial
level will be included in the study. Demographic details will be noted.
General anesthesia with prone positioning. Cervical pedicle screws will be
inserted at different levels from C3 to C6 with the help of intra-operative
O-arm and navigation. Burr is used for making the entry into cervical pedicle
under guidance of navigation at all the planned levels followed by screw
insertion according to the dimensions calculated on screen. Screen shots during
insertion on navigation screen will be recorded and final post-op CT scan will
be studied. Anatomical entry point , accuracy of pedicle screws, angle of
insertion, time taken for each screw, over
all radiation, length of skin incision and breach rate will be recorded. |