Intervertebral Disc Degeneration, Spinal Deformity, Spinal Instability, Spondylolisthesis, Stenosis, Spinal
Conditions
Keywords
Spine, Surgery, Adult, Neuromonitoring, Electromyography, Somatosensory evoked potentials
Brief summary
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk during the lateral lumbar interbody fusion (LLIF) procedure.
Interventions
DIAGNOSTIC_TESTSomatosensory evoked potential [SSEP] intraoperative monitoring
No study specific intervention is performed. Intraoperative neuromonitoring system that is observed in this study is for assessing the health of the lumbar plexus during lateral lumbar interbody fusion surgery
Sponsors
Alphatec Spine, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age at the time of planned surgery. * Indicated for 1- or 2-level instrumented LLIF surgery (in either prone or lateral decubitus positions), inclusive of the L4-5 disc space. * Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion criteria
* Patients requiring surgical treatment at more than 2 lumbar levels. * Patients with peripheral neuropathy such as from diabetes or other conditions that might affect the reliability of intraoperative neuromonitoring. * Patients with prior history of partial/full hip or knee joint replacement surgery (i.e., arthroplasty or resurfacing) on the leg targeted for saphenous monitoring and electrode placement. * Patients with presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. * Female patients who are pregnant or wanting to become pregnant during the timeframe of study participation. * Patients participating in another clinical study which may compromise this study's results or compliance with this study's procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits | 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months. | This outcome measure determines the utility of the saphenous nerve SSEP monitoring based on the correlation of intraoperative neuromonitoring results with new or worsened postoperative neural deficits, as measured by motor and sensory physical exam. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities. | 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months. | This outcome measure includes: * Correlating specific monitoring findings with incidence of new or worsened motor or sensory deficits post-operatively and their correlation with patient-specific and surgical factors. * Correlating patient and surgical factors with new and worsened postoperative neural deficits. |
Countries
United States
Outcome results
None listed