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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05710016

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spine Injuries and Disorders

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].

Study Design

Study Type:

Observational

Anticipated Enrollment :

64 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Measurement the incidence of new neurologic deficits (NNDs) and estimate sensitivity and specificity of IONM modalities [immediate measurement]
neurological examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

shady nady zaky, principle investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05710016

Other Study ID Numbers:

Spine Surgery Neuromonitoring

First Posted:

Feb 2, 2023

Last Update Posted:

Feb 2, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Injuries

Study Results

No Results Posted as of Feb 2, 2023