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Evaluation Of Intra-Operative Neuro-Monitoring Alarm During Complex Spine Surgery

Evaluation Of Intra-Operative Neuro-Monitoring Alarm During Complex Spine Surgery

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05710016
Enrollment
64
Registered
2023-02-02
Start date
2023-04-01
Completion date
2023-12-31
Last updated
2023-02-02

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

Conditions

Spine Injuries and Disorders

Brief summary

Iatrogenic spinal cord injury is the most feared complication of complex spine surgery. The incidence of neurological complications for spinal deformity surgery has been estimated by the Scoliosis Research Society as 1%, except when a combined approach is used, where the rate increases to 1.87% \[1\]. Intraoperative neuromonitoring (IONM) techniques are usually implemented during spine surgery to avoid nefarious abuse of the nervous system, which can cause postoperative problem \[2\]. In 1992 a Scoliosis Research Society study concluded that the use of intraoperative spinal cord neurophysiological monitoring during operative procedures including instrumentation should be considered ''a viable alternative as well as an adjunct to the use of the wake-up test during spinal surgery'' \[5\]. The benefit of using neuromonitoring has been validated by numerous studies involving scoliosis correction, revision surgeries and vertebral osteotomies.

Detailed description

The trend in IONM usage in the current literature, which may be a direct consequence of improved efficacy of the procedure, and the development of optimized treatment algorithm \[6\]. Nevertheless, it is well known that the use of somatosensory evoked potentials (SEPs) alone may be ineffective in detecting a motor tract deficit \[7, 8\]. As a result, various methods for monitoring the motor tract of the spinal cord have been developed. The most commonly used stimulation technique is transcranial electric stimulation (TES) of the primary motor cortex by corkscrew electrodes placed in the scalp, to produce myogenic motor evoked potential\[9\]. The combination of SEPs and TES-MEPs provides global monitoring coverage of spinal cord function \[10\]. Based on the available evidence, it is recommended that the use of multimodality neuromonitoring be considered in complex spine surgery where the spinal cord or nerve roots are deemed to be at risk \[11\].

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* patient with spine deformities * patient with sever cervical and lumbar degenerative diseases * patient with combined cervical and lumbar diseases * patient with spine tumours

Exclusion criteria

• cases with mild to moderate degenerative diseases simple spine procedures

Design outcomes

Primary

MeasureTime frameDescription
Measurement the incidence of new neurologic deficits (NNDs) and estimate sensitivity and specificity of IONM modalitiesimmediate measurementneurological examination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026