| CTRI Number |
CTRI/2024/08/072947 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating Handheld Metal Detectors for Spinal Implant Detection |
|
Scientific Title of Study
|
Detection of Modern Spinal Implants by Handheld Metal Detectors |
| 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 |
Room no. 9, second floor Annexe,Department Research department.Stavya spine hospital and Research
Institute,Ellisbridge,Mithakhali.Ahmadabad GUJARAT |
| 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,Department:Research department, Stavya spine hospital and Research Institute Annexe,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: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
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 |
100 consecutive patients undergoing cervical spine, dorsal and lumbar spine instrumenta-tion with implants will be recruited |
|
| ExclusionCriteria |
| Details |
Patients with prior history of spinal instrumentation.
Patients with pacemakers or other implanted metallic hardware that can interfere with detection of spinal implant |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Demographic profile and BMI
Region of spine operated
Metal used
Number of levels
Anterior or posterior surgery
Number and type of implants
Weight of implants |
This is a single point study requiring no further follow up or clinic visits from the patient for the purpose of data collection |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/09/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Over the past two decades, security measures have increased and travellers are subjected to screening with hand held metal detectors at airports, railway station and even hotels. This has increased the concern among patients undergoing spine surgery that they will set off these detectors leading to a subsequent delay in travel in order to be subjected to further screening. Data specific to the detection of spinal implants using these devices is scarce. Our study aims to assess the detection rates of commonly used spinal implants in different regions of the spine and to understand the factors influencing the detection rate. |