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Study Comparing 3D Navigation and Standard Imaging Methods in Minimally Invasive Lower Back Spine Surgery

Impact of Intraoperative 3D Navigation versus Conventional Fluoroscopy on Clinical, Radiographic, and Operational Outcomes in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MIS TLIF) - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/06/111659
Enrollment
180
Registered
2026-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Health Condition 1: M513- Other thoracic, thoracolumbar andlumbosacral intervertebral disc degeneration

Interventions

Sponsors

Stavya Spine Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diagnosis of degenerative disc disease, spinal stenosis, or Grade 1 2 spondylolisthesis. 2. Single or multi-level MIS TLIF performed using either conventional fluoroscopy or 3D navigation. 3. Availability of comprehensive Hospital medical records and postoperative imaging.

Exclusion criteria

Exclusion criteria: 1. Revision spine surgery at the index level. 2. Active spinal infection or acute trauma. 3. Severe osteoporosis requiring alternative fixation strategies.

Design outcomes

Primary

MeasureTime frame
1.Pedicle screw placement accuracy - (Assessed using Gertzbein Robbins grading on postoperative CT/MRI; Grades A & B considered acceptable) 2.Incidence and grading of proximal facet joint violation (PFJV) (Grade 1 vs Grade 2 cranial facet joint violation by uppermost pedicle screws)Timepoint: Data will be analyzed at 2 weeks, 6 weeks, 3 months, 6 months and 12 months.

Secondary

MeasureTime frame
1.Operative efficiency: Operative time, estimated blood loss, fluoroscopy time and radiation dose 2.Early recovery: Time to ambulation, opioid consumption, length of hospital stay 3.Multi-level efficiency: Operative time per levelTimepoint: Data will be analyzed at 2 weeks, 6 weeks, 3 months, 6 months and 12 months.

Countries

India

Contacts

Public ContactDr Mirant Dave

Stavya Spine Hospital And Research Institute

mirantdave172@gmail.com09099597234

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026