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

Spine Injuries and Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05710016
• Other study ID #: Spine Surgery Neuromonitoring
• Status: Not yet recruiting
• Start date: April 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Injuries
• Spine Injuries and Disorders

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement the incidence of new neurologic deficits (NNDs) and estimate sensitivity and specificity of IONM modalities	neurological examination	immediate measurement