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

NCT05710016 | Unknown

• 1 other identifier: Spine Surgery Neuromonitoring
• Study Type: observational
• Target: 64
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spine Injuries and Disorders

Outcome Measures

Primary Outcomes (1)

• Measurement the incidence of new neurologic deficits (NNDs) and estimate sensitivity and specificity of IONM modalities

  neurological examination

  immediate measurement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

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

You may not qualify if:

• cases with mild to moderate degenerative diseases simple spine procedures

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 2, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 2, 2023

Record last verified: 2023-01