Comparing the accuracy and safety of pedicle screw placement in thoracolumbar spine by three different surgical techniques( Freehand, O-arm navigated and Robot assisted) .

Triple Randomised Controlled Trial comparing the accuracy and safety between Freehand, O-arm navigated And Robot assisted pedicle screw placement in thoracolumbar spine.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/05/042550

Enrollment

Registered

2022-05-13

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: S320- Fracture of lumbar vertebra Health Condition 2: S220- Fracture of thoracic vertebra Health Condition 3: T844- Mechanical complication of other internal orthopedic devices, implants and grafts Health Condition 4: M41- Scoliosis Health Condition 5: M532- Spinal instabilities Health Condition 6: M431- Spondylolisthesis Health Condition 7: M51- Thoracic, thoracolumbar, and lumbosacral intervertebral disc disorders Health Condition 8: A180- Tuberculosis of bones and j

Interventions

Intervention1: Pedicle screw placement by free hand technique.: Placing pedicle screws in thoracolumbar spine by free hand technique for different spinal pathologies and comparing the safety and accur

Eligibility

Inclusion criteria

Inclusion criteria: 1). Patients of either sex and of any age group. 2). Patients giving informed and written consent. 3). Any patient requiring pedicle screw fixation by posterior approach in thoracolumbar spine

Exclusion criteria

Exclusion criteria: 1).patient not giving informed and written consent 2).spine patient operated by anterior approach.

Design outcomes

Primary

Measure	Time frame
1.No.of screws contained within the pedicle as per Gertzbein and Robbins system. 2.No of breaches and direction of the breach. 3.Time taken for screw insertion(per screw). 4. No. of cases converted to free-hand and their causes(failure of navigation/Robot-assisted techniques). 5. Length of postoperative hospital stay. 6). Postoperative complications and possible explanations to it. 7. Clinical complications (relevant to screw malpositioning).Timepoint: At baseline,2weeks,6weeks and 3 months	—

Measure

Time frame

1.No.of screws contained within the pedicle as per Gertzbein and Robbins system. 2.No of breaches and direction of the breach. 3.Time taken for screw insertion(per screw). 4. No. of cases converted to free-hand and their causes(failure of navigation/Robot-assisted techniques). 5. Length of postoperative hospital stay. 6). Postoperative complications and possible explanations to it. 7. Clinical complications (relevant to screw malpositioning).Timepoint: At baseline,2weeks,6weeks and 3 months

—

Secondary

Measure	Time frame
1).Total operative time. 2).Total radiation exposure [radiation per screw calculated in terms of dose area product(DAP)]. 3).Learning curve.Timepoint: At baseline,2weeks,6weeks and 3 months	—

Countries

India

Contacts

Public ContactDr Saumashankar Dey

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

drbhavukgarg@gmail.com9899558021

Outcome results

None listed

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