Validation of bipolar pedicle stimulation in transpedicular lumbar fusion

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003695

Enrollment

300

Registered

2012-04-18

Start date

2012-01-09

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

lumbar instability

Interventions

Group 1: monopolar vs. bipolar stimulation at the level of the neuroforamen

monopolar vs. bipolar stimulation inside the vertebral body

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: adult competent patients with planned lumbar transpedicular spondylodesis between L2 and S1; in revision cases, the newly instrumented levels can be included, if between L2 and S1; in longer instrumenation above L2 and/or below S1, the levels between L2 and S1 can be included

Exclusion criteria

Exclusion criteria: implanted cardiac pacemaker or deep brain stimulation; in revision cases, the previous instrumented levels can not be included; in longer instrumentation, the levels above L2 an/or below S1 are excluded

Design outcomes

Secondary

Measure	Time frame
Selectivity of bipolar vs. monopolar nerve stimulation	—

Primary

Measure	Time frame
Sensitivity and specificity of bipolar stimulation vs. monopolar stimulation with regard to intraoperative pedicle perforation	—

Countries

Germany

Contacts

Public ContactRonen Sircar

Universitätsklinikum Freiburg Neurochirurgische Universitätsklinik

ronen.sircar@uniklinik-freiburg.de0761/270-93530

Outcome results

None listed

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