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CTRI Number  CTRI/2024/01/061541 [Registered on: 16/01/2024] Trial Registered Prospectively
Last Modified On: 04/06/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Evaluating the precision of robotic spine surgery plans by comparing them with post-operative CT scans to determine their accuracy in achieving desired outcomes. 
Scientific Title of Study   Accuracy Assessment of Planned vs. Actual Trajectories in Robotic Spine Surgery Using Post-Operative CT scans 
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 Mirant B 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  9099597234  
Fax  07926408174  
Email  mirantdave172@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mirant B 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  9099597234  
Fax  07926408174  
Email  mirantdave172@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mirant B 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  9099597234  
Fax  07926408174  
Email  mirantdave172@gmail.com  
 
Source of Monetary or Material Support  
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 
 
Primary Sponsor  
Name  Stavya Spine Hospital and Research Institute 
Address  Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mirant Dave  Stavya Spine Hospital & Research Institute  No. 9 2nd floor Annexe Research department Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 GUJARAT
Ahmadabad
GUJARAT 
9099597234
07926408174
mirantdave172@gmail.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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M431||Spondylolisthesis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Candidates for spinal surgery that involves the use of the robotic system.
- Patients who have provided their informed consent to participate in the study. 
 
ExclusionCriteria 
Details  Are unable to provide informed consent due to cognitive impairments or other reasons.
Have contraindications for robotic spine surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Conduct post-operative assessments to evaluate complications, post-operative pain
levels, recovery times, and other relevant clinical outcomes. 
patient have to come for follow up after 3 months,6 months and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   21/01/2024 
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  
a. The study on the accuracy of planned trajectories versus real trajectories in robotic spine surgery is
significant due to several reasons:
1. Patient Safety: Spine surgery is a delicate procedure where precision is paramount. Errors in the
execution of planned trajectories can lead to serious complications, potentially harming patients.
Assessing the accuracy of robotic-assisted procedures ensures patient safety.
2. Evolving Technology: Robotic assistance in spine surgery is an evolving technology with the potential
to enhance surgical outcomes. This study is essential to validate the effectiveness of these systems and
identify areas for improvement.
3. Clinical Decision-Making: Accurate execution of planned trajectories influences clinical decisions.
Surgeons rely on these plans for guidance during the procedure, making it vital to assess their reliability.
4. Quality Improvement: Identifying disparities between planned and actual trajectories can drive quality
improvement initiatives in spine surgery. This study can lead to refinements in surgical techniques and
technology.
5. Data-Driven Medicine: The study contributes to the growing field of data-driven medicine, where
objective data and analytics are used to make informed decisions in healthcare, ultimately improving
patient care.
This study’s significance lies in its potential to improve patient safety, validate robotic-assisted
technology, enhance clinical decision-making, drive quality improvement, and contribute to the
advancement of data-driven medicine in the field of spine surgery.
b. The role of robotics in spine surgery has been steadily growing, driven by advancements in
technology and the pursuit of improved patient outcomes. Here’s some context for the increasing
prominence of robotics in spine surgery:
1. Precision and Accuracy: Robotics offers a level of precision and accuracy that is often challenging to
achieve with traditional surgical techniques. This is particularly crucial in spine surgery, where millimeterlevel
precision is required to avoid damage to critical structures.
2. Minimally Invasive Approaches: Robotic systems enable minimally invasive spine surgery (MISS), which
involves smaller incisions and reduced tissue damage. This leads to quicker recovery times, less postoperative
pain, and shorter hospital stays.
3. Enhanced Visualization: Robotic platforms often include advanced imaging systems that provide
surgeons with real-time, high-definition 3D views of the surgical site. This enhanced visualization aids in
better decision-making during surgery.
4. Improved Patient Outcomes: The use of robotics has been associated with better patient outcomes,
including reduced complications, lower infection rates, and improved long-term functionality and quality
of life for patients undergoing spine surgery.
5. Surgeon Training and Skill Enhancement: Robotics allows for the standardization of surgical
techniques, making it easier for surgeons to adopt and master new procedures. It can also assist lessexperienced
surgeons in performing complex spinal surgeries more safely.
6. Complex Procedures: Robotics is particularly valuable in complex spinal procedures, such as those
involving deformity correction, tumor resection, and complex fusion surgeries. These procedures benefit
from the precision and stability that robotic systems provide.
7. Research and Data Collection: Robotic systems generate vast amounts of data during surgery, which
can be used for research and quality improvement. This data-driven approach is becoming increasingly
important in the field of spine surgery.
8. Patient Demand: Patients are increasingly seeking less invasive and more technologically advanced
surgical options. The availability of robotic-assisted spine surgery can attract patients and meet their
expectations for advanced healthcare.
9. Market Growth: The medical robotics industry has been expanding rapidly, with increased investment
and competition leading to the development of more sophisticated and accessible robotic systems for
spine surgery.
The growing role of robotics in spine surgery is driven by the pursuit of enhanced precision, minimally
invasive approaches, improved patient outcomes, and the adoption of advanced technology. As the field
continues to evolve, robotics is expected to play an increasingly vital role in the treatment of spinal
conditions.
c. Assessing the accuracy of planned trajectories in robotic spine surgery is essential for ensuring
patient safety and surgical success due to several critical reasons:
1. Precision and Avoidance of Critical Structures: Planned trajectories guide the robotic system to
navigate around sensitive spinal structures such as nerves and blood vessels. Ensuring the accuracy of
these planned paths is vital to prevent inadvertent damage to these critical anatomical elements, which
can lead to catastrophic complications.
2. Minimizing Complications: Inaccurate trajectories can result in complications such as nerve damage,
vascular injury, or cerebrospinal fluid leaks. Accurate execution of planned trajectories reduces the risk
of these complications, enhancing patient safety and minimizing post-operative issues.
3. Surgical Efficiency: Accurate trajectory execution minimizes the need for intraoperative adjustments,
which can prolong surgery and increase the time patients spend under anesthesia. A more efficient
surgery reduces the overall risk to the patient and contributes to surgical success.
4. Optimal Hardware Placement: In spinal fusion procedures, the placement of screws and other
hardware must be precise for successful fusion and long-term stability. Deviations from the planned
trajectories can lead to suboptimal hardware placement, which may compromise the effectiveness of
the procedure.
5. Functional Outcomes: The accuracy of planned trajectories directly impacts the functional outcomes
of spine surgery. Precise execution ensures that the intended corrective or stabilizing measures are
achieved, contributing to the long-term success of the surgery.
6. Minimally Invasive Surgery: Many robotic-assisted spine surgeries are performed using minimally
invasive techniques. Accurate trajectory execution is especially crucial in these procedures, as the margin
for error is narrower, and there is a higher reliance on pre-operative planning.
7. Patient Confidence: Patients undergoing spine surgery often have high expectations for the precision
and safety of the procedure. Ensuring the accuracy of planned trajectories not only meets these
expectations but also instills confidence in the healthcare system, leading to improved patient
satisfaction.
8. Reduction of Revision Surgeries: Inaccurate trajectories that result in suboptimal outcomes may
necessitate revision surgeries, which are associated with increased risks and costs. Accurate planning
and execution can reduce the need for such revisions, enhancing surgical success.
9. Data-Driven Improvement: Analyzing the accuracy of planned trajectories allows for continuous
improvement in robotic spine surgery techniques. Identifying discrepancies can lead to refinements in
the planning and execution processes, further enhancing patient safety and surgical success over time.
Assessing the accuracy of planned trajectories is a fundamental aspect of robotic spine surgery that
directly impacts patient safety, surgical success, and overall healthcare quality. It ensures that the
procedure is carried out with the utmost precision, minimizing risks and maximizing the benefits for
patients undergoing spinal surgery.
 
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