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Evaluating Robotic Technology for Thoracic Pedicle Screw Placement Across Multiple Spine Centers

A Prospective Multicentric Trial on Accuracy, Efficiency, Safety, and Outcomes of Robot-Assisted Thoracic Pedicle Screw Fixation. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/110946
Enrollment
100
Registered
2026-05-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: S220- Fracture of thoracic vertebra

Interventions

Intervention1: Nil: Nil

Sponsors

India Medtronic Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 18 65 years, with indications for thoracic pedicle screw fixation (due to trauma, deformity, tumor, infection, or degenerative conditions), and the ability to provide written informed consent

Exclusion criteria

Exclusion criteria: Patients unable to undergo imaging, those with severe comorbidities precluding surgery, patients unable to complete follow-up, or those providing negative consent to participate.

Design outcomes

Primary

MeasureTime frame
post procedure O-arm spin or postoperative CT scans uploaded in DICOM format by the participating centres and classified based on the Gertzbein-Robbins scaleTimepoint: post procedure O-arm spin or postoperative CT scans uploaded in DICOM format by the participating centres and classified based on the Gertzbein-Robbins scale—

Secondary

MeasureTime frame
B) Secondary Outcomes 1. Safety: a. Incidence of intraoperative complications (e.g., robotic system errors, hardware-related issues, facet violation etc.) b. Postoperative complications (e.g., neurological, vascular, or infection-related events etc.) 2. Operative Parameters: Estimated blood loss 3. Efficiency: a. Number of attempts per screw b. Registration time - from start to completion of registration c. Planning time - time required for planning of screws. d. Screw insertion time - from docking of the robotic arm to the screw placement completion. e. Total procedure time - from start of registration to screw placement completion 4. Radiation exposure : Measured in mSv Timepoint: post procedure O-arm spin or postoperative CT scans uploaded in DICOM format by the participating centres and classified based on the Gertzbein-Robbins scale—

Countries

India, Malaysia, Singapore, Thailand

Contacts

Public ContactHarvinder Singh Chhabra

Sri Balaji Action Medical Institute

hschhabrascientific@gmail.com09810681854

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026