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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult undergoing 1- or 2-level lateral lumbar interbody fusion surgery, inclusive of the L4-5 level |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Somatosensory evoked potential [SSEP] intraoperative monitoring | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of SSEP neuromonitoring in post-operative clinical diagnosis of motor/sensory deficits | 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. | 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the positive predictive value (PPV) and negative predictive value (NPV) of free run and SSEP monitoring modalities. | This outcome measure includes:
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients of both sexes undergoing LLIF surgery atone or two levels inclusive of the L4-5 level.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alphatec Spine Inc. | Recruiting | Carlsbad | California | 92008 | United States |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| ID | Term |
|---|---|
| D005073 | Evoked Potentials, Somatosensory |
| D016343 | Monitoring, Intraoperative |
| ID | Term |
|---|---|
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
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|
| 6 weeks or until new or worsened neural deficits are resolved, but not exceeding 12 months. |
| D055009 |
| Spondylosis |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D008991 | Monitoring, Physiologic |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013514 | Surgical Procedures, Operative |