Symptoms and General Pathology

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Diseases and Abnormalities at or Before Birth

Hypertrophy

Spondylitis

Constriction, Pathologic

Spondylarthritis

Intervertebral Disc Displacement

Intervertebral Disc Degeneration

Spinal Stenosis

Spondylosis

Spinal Curvatures

Spinal Neoplasms

Osteoarthropathy, Primary Hypertrophic

Communicable Diseases

Bone Diseases

Bone Diseases, Infectious

Spinal Diseases

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Pathological Conditions, Anatomical

Hernia

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Genetic Diseases, Inborn

During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from all patients who consent to participate in the study. EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient.

Two intracorporal electrode needles will be inserted beneath the skin of the genitalia. After insertion, the electrodes will be secured and connected by leads to two standard neurophysiological devices for differential amplification, display, and storage. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.

Autonomic nervous system monitoring

Anna Lintelmann, MPH

Amy Schrecengost, BS

Nilanjana Banerji, MS, PhD

Stanley Skinner, MD

A safety and feasibility study of free-run and stimulated corporal electromyography (EMG) to assess autonomic neural function during spinal and/or pelvic surgery in women and men.

This is a safety and efficacy trial to assess autonomic neural function monitoring during spinal and/or pelvic surgery.

During standard intraoperative neuromonitoring, additional smooth muscle free-running and stimulated EMG will be recorded from corporal tissues (corpus spongiosum) of male and female genitalia from individual patients. Throughout the duration of the spinal surgery, the neurophysiologist will continuously monitor autonomic function. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.

EMG data and additional demographics and clinical data (e.g. operative time, adverse events) will be collected for each patient. The success rates of 1) credible and safe EMG recording and 2) positive EMG responses to each stimulation method will be calculated.

Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study

Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency, will be recorded.

Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuations in amplitude and/or frequency in response to IOMN (intraoperative neuromonitoring) stimulations and recordings, will be recorded.

Stanley Skinner

Neurophysiologist

Spondylolisthesis

Spondylolysis

Pedicle screw system

The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.

Safety and Efficacy of the CarboFix Pedicle Screw System

CarboFix Pedicle Screw System

CarboFix Orthopedics Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Protection of Autonomic Nervous System During Lower Spine Surgical Procedures: A Safety and Feasibility Study	NCT02873182	Intervertebral ... Intervertebral ... Spinal Curvatur... Spinal Stenosis Spondylitis Spondylosis Osteoarthropath... Spinal Neoplasm...	Autonomic nervo...	18 Years - 70 Years	Allina Health System
Safety and Efficacy of the CarboFix Pedicle Screw System	NCT02039232	Degenerative Di... Spondylolisthes... Spinal Stenosis Spinal Curvatur... Tumor	Pedicle screw s...	18 Years -	CarboFix Orthopedics Ltd.

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