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

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. - CxPS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/04/032866
Enrollment
50
Registered
2021-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M95-M95- Other disorders of the musculoskeletal system and connective tissue

Interventions

None listed

Sponsors

Stavya Spine Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Cervical anterior surgery. 2. Cervical laminectomy without fusion. 3. Lateral mass screw fixation.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: 24 Months

Secondary

MeasureTime frame
To evaluate the insertion angle, screw breach using postoperative multi-planar computerized tomography scans. Radiation dosage and screw insertion time are looked for. Timepoint: 24 Months

Countries

India

Contacts

Public ContactDr Birju K Vyas

Stavya Spine Hospital And Research Institute

birju_spine@yahoo.com09925248584

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026