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A comparative study Between O-arm navigation Vs Free hand technique for the placement of pedicle screws in the treatment of spinal disorders

Use of O-arm navigational technique versus Free hand standard method in pedicle screws placement for the treatment of Spinal disorders: A randomised controlled trial - FROST

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/12/022340
Enrollment
100
Registered
2019-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: M849- Disorder of continuity of bone, unspecified

Interventions

Intervention1: Free hand technique: pedicle screws will be placed by operating surgeon by standard free hand technique Control Intervention1: O arm navigational technique: OArm is a navigational machi

Sponsors

DHR ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients fit for surgery willingness to participate

Exclusion criteria

Exclusion criteria: patients unfit for surgery Unwillingness to participate

Design outcomes

Primary

MeasureTime frame
1. Accuracy of pedicle placement 2. neurological deficit or deteriorationTimepoint: baseline, 3rd day of surgery

Secondary

MeasureTime frame
Neurological deficitTimepoint: baseline, 12 weeks, 24 weeks and 48th week

Countries

India

Contacts

Public ContactDr Bhavuk Garg

AIIMS New Delhi

drbhavukgarg@gmail.com

Outcome results

None listed

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