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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 64

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All cases arrived in our facility meets our inclusion criteria within one year .

Estimated number of cases based on our hospital records for the last year was 64 cases .

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement the incidence of new neurologic deficits (NNDs) and estimate sensitivity and specificity of IONM modalities	neurological examination	immediate measurement

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2023
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: January 25, 2023
• First Posted (ACTUAL): February 2, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 2, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Back Injuries; Spinal Injuries
• Other Study ID Numbers: Spine Surgery Neuromonitoring

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No