Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204900
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2024-01-03
Brief Title:
A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery
Sponsor:
Retropsoas Technologies LLC
Organization:
Retropsoas Technologies LLC
Study Overview
Official Title:
Evaluation Of A Novel Technique To Monitor Neurophysiological Activity During TLIF Surgery Using The Endoscopic Assisted Retropsoas EARP Nerve Cuff Electrode and Retractor With A Commercially Available Lumbar Spine Retractor System
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the differences the effectiveness and the safety between two different nerve and muscle monitoring devices currently available during a TLIF surgery
The Endoscopic Assisted Retropsoas EARP Nerve Cuff Electrode and Retractor surgical and nerve monitoring tools will be used in addition to standard nerve monitoring tools during the surgery The choice of standard nerve monitoring equipment is based on the decision of the surgeon and technologist and is not dictated by this study
These tools will be compared with regards to safety and ability to accurately monitor the nervous system during the surgery
The Endoscopic Assisted Retropsoas EARP Nerve Cuff Electrode and Retractor surgical and nerve monitoring tools will be used in addition to standard nerve monitoring tools during the surgery The choice of standard nerve monitoring equipment is based on the decision of the surgeon and technologist and is not dictated by this study
These tools will be compared with regards to safety and ability to accurately monitor the nervous system during the surgery
Detailed Description:
The application of traditional SSEPs and tcMEPs to lumbar nerve root monitoring during TLIF surgery is both challenging and problematic When applied to lumbar nerve root monitoring SSEPs and tcMEPs unfortunately suffer in specificity sensitivity or both A surgeon thus cannot confidently rely on these techniques to monitor nerve root function and must guess the likelihood of dysfunction
Spontaneous EMG sEMG is also used to monitor nerve root activity While sEMG is an excellent indicator of spinal nerve root manipulation it is a poor diagnostic indicator of dysfunction 90-95 of sEMG alerts are not associated with dysfunction yielding a high false positive rate and poor specificity and postoperative deficits are often not associated with sEMG alerts yielding many false negatives and poor sensitivity The primary utility of sEMG is to use as an indicator of manipulation which prompts the acquisition of tcMEPs to assess function
There is a clear need to take the guesswork out of monitoring the functional status of nerve roots at risk during lumbar decompressions and select interbody fusions During TLIFs the exiting nerve root is at risk as it courses obliquely across disc space encroaching on the surgical corridor Standardly a hand-held retractor is used to retract and protect the nerve root during disc space preparation implant insertion or even simple decompression This maneuver and retraction place a particular nerve root at risk but again traditional SSEP and tcMEPs are not ideal for monitoring that risk
The EARP Nerve Cuff Electrode Retropsoas Technologies is a novel Class II device that is 510k cleared by FDA It conducts electrical signals as a component of intraoperative neuromonitoring is used with commercially available neuromonitoring systems and does not stimulate or record the signal itself The standard connectors at the proximal end interface with the neuromonitoring equipment The distal nerve cuff electrode partially encircles and contacts the target nerve root It uses a bipolar configuration to limit current spread It is available in several inner diameters to accommodate variability in patient nerve root size anatomy
The EARP Retractor is a Class I device used with a commercially available Retractor system and is only used as an additional 4th blade
In TLIF surgery the exiting nerve must be retracted to allow for sufficient access to the intervertebral disc space The retraction is applied at the medial portion of the nerve root The application of this retraction may produce activity in the nerve root andor conduction changes in the nerve root due to temporary manipulation compression or ischemia related to the retraction1
The objective of the study is to demonstrate the ability to safely monitor lumbar nerve root activity and function during retraction using an Endoscopic Assisted Retropsoas EARP Nerve Cuff Electrode and an EARP Retractor system during a standard Transforaminal Lumbar Interbody Fusion TLIF with improved specificity and sensitivity over traditional monitoring techniques
Spontaneous EMG sEMG is also used to monitor nerve root activity While sEMG is an excellent indicator of spinal nerve root manipulation it is a poor diagnostic indicator of dysfunction 90-95 of sEMG alerts are not associated with dysfunction yielding a high false positive rate and poor specificity and postoperative deficits are often not associated with sEMG alerts yielding many false negatives and poor sensitivity The primary utility of sEMG is to use as an indicator of manipulation which prompts the acquisition of tcMEPs to assess function
There is a clear need to take the guesswork out of monitoring the functional status of nerve roots at risk during lumbar decompressions and select interbody fusions During TLIFs the exiting nerve root is at risk as it courses obliquely across disc space encroaching on the surgical corridor Standardly a hand-held retractor is used to retract and protect the nerve root during disc space preparation implant insertion or even simple decompression This maneuver and retraction place a particular nerve root at risk but again traditional SSEP and tcMEPs are not ideal for monitoring that risk
The EARP Nerve Cuff Electrode Retropsoas Technologies is a novel Class II device that is 510k cleared by FDA It conducts electrical signals as a component of intraoperative neuromonitoring is used with commercially available neuromonitoring systems and does not stimulate or record the signal itself The standard connectors at the proximal end interface with the neuromonitoring equipment The distal nerve cuff electrode partially encircles and contacts the target nerve root It uses a bipolar configuration to limit current spread It is available in several inner diameters to accommodate variability in patient nerve root size anatomy
The EARP Retractor is a Class I device used with a commercially available Retractor system and is only used as an additional 4th blade
In TLIF surgery the exiting nerve must be retracted to allow for sufficient access to the intervertebral disc space The retraction is applied at the medial portion of the nerve root The application of this retraction may produce activity in the nerve root andor conduction changes in the nerve root due to temporary manipulation compression or ischemia related to the retraction1
The objective of the study is to demonstrate the ability to safely monitor lumbar nerve root activity and function during retraction using an Endoscopic Assisted Retropsoas EARP Nerve Cuff Electrode and an EARP Retractor system during a standard Transforaminal Lumbar Interbody Fusion TLIF with improved specificity and sensitivity over traditional monitoring techniques
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None