Study of new technique to insert pedicle screw in cervical spine using advanced technologies (O-arm and Navigation) in Indian subjects

Completed

Conditions: Other disorders of the musculoskeletal system and connective tissue,

Brief Summary: All the patients operated for various cervical pathologies in sub axiallevel will be included in the study. Demographic details will be noted.General anesthesia with prone positioning. Cervical pedicle screws will beinserted at different levels from C3 to C6 with the help of intra-operativeO-arm and navigation. Burr is used for making the entry into cervical pedicleunder guidance of navigation at all the planned levels followed by screwinsertion according to the dimensions calculated on screen. Screen shots duringinsertion on navigation screen will be recorded and final post-op CT scan willbe studied. Anatomical entry point , accuracy of pedicle screws, angle ofinsertion, time taken for each screw, overall radiation, length of skin incision and breach rate will be recorded.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
To evaluate the insertion angle, screw breach using postoperative multi-planar computerized tomography scans.	Radiation dosage and screw insertion time are looked for.

Locations (1): Stavya Spine Hospital & Research Institute
🇮🇳
Ahmadabad, GUJARAT, India
Stavya Spine Hospital & Research Institute
🇮🇳Ahmadabad, GUJARAT, India
Dr Bharat R Dave
Principal investigator
9825019913
brd_172@yahoo.com