Comparing the accuracy and safety of pedicle screw placement in thoracolumbar spine by three different surgical techniques( Freehand, O-arm navigated and Robot assisted) .
Phase 2
- Conditions
- Health Condition 1: S320- Fracture of lumbar vertebraHealth Condition 2: S220- Fracture of thoracic vertebraHealth Condition 3: T844- Mechanical complication of other internal orthopedic devices, implants and graftsHealth Condition 4: M41- ScoliosisHealth Condition 5: M532- Spinal instabilitiesHealth Condition 6: M431- SpondylolisthesisHealth Condition 7: M51- Thoracic, thoracolumbar, and lumbosacral intervertebral disc disordersHealth Condition 8: A180- Tuberculosis of bones and joints
- Registration Number
- CTRI/2022/05/042550
- Lead Sponsor
- AIIMS NEW DELHI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
1).patient not giving informed and written consent
2).spine patient operated by anterior approach.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.No.of screws contained within the pedicle as per Gertzbein and Robbins system. <br/ ><br>2.No of breaches and direction of the breach. <br/ ><br>3.Time taken for screw insertion(per screw). <br/ ><br>4. No. of cases converted to free-hand and their causes(failure of navigation/Robot-assisted techniques). <br/ ><br>5. Length of postoperative hospital stay. <br/ ><br>6). Postoperative complications and possible explanations to it. <br/ ><br> 7. Clinical complications (relevant to screw malpositioning).Timepoint: At baseline,2weeks,6weeks and 3 months
- Secondary Outcome Measures
Name Time Method 1).Total operative time. <br/ ><br>2).Total radiation exposure [radiation per screw calculated in terms of dose area product(DAP)]. <br/ ><br>3).Learning curve.Timepoint: At baseline,2weeks,6weeks and 3 months