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Handheld iOS-based spinal navigation versus computer tomography-based image guided navigation in the placement of thoracolumbar pedicle screws; protocol of a randomized controlled trial

Handheld iOS-based spinal navigation versus computer tomography-based image guided navigation in the placement of thoracolumbar pedicle screws; protocol of a randomized controlled trial - iNav navigation study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55222
Enrollment
167
Registered
2020-07-12
Start date
2022-05-16
Completion date
Unknown
Last updated
2026-04-14

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

Conditions

spondylolisthesis

Interventions

Patients undergoing spinal navigated instrumentation will be randomized into one group in which pedicle screws will be inserted by guidance of the iNav system, and one group in which pedicle screw w

Sponsors

Circinus Medical Technology
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Patients older than 18 years - informed consent - single or multilevel fusions (T12 to S1) for the following indications: degenerative spinal stenosis spondylolisthesis degenerative disc disease failed back surgery syndrome.

Exclusion criteria

Exclusion criteria: - cervical surgery and thoracic surgery above T12. - trauma, infection, and tumor. - cortical trajectory screw fixation.

Design outcomes

Primary

MeasureTime frame
The main endpoint is the accuracy of the pedicle screw position according to the classification of Gertzbein and Robbins in which Grade A and B are defined as *good position*, based on the computertomography imaging at the end of each surgical procedure.

Secondary

MeasureTime frame
Other study parameters are duration of surgery, complications, and length of hospital stay.

Countries

Netherlands

Contacts

Public ContactM.P. Arts

Haaglanden Medisch Centrum (HMC)

m.arts@haaglandenmc.nl0889794365

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026