/ Not yet recruitingNot Applicable A Multi-Center Post-Marketing Data Collection Protocol to Evaluate the Safety, Performance, and Health Economics of the Endoscopic Assisted Retropsoas (EARP) Interbody System for Lumbar Interbody Fusion Surgery
The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.
The primary objectives are:
* To evaluate the safety of the EARP surgical technique and devices during LIF surgeries.
* To understand the EARP fusion system's ability to achieve fusion and improve disk space over time.
/ RecruitingNot Applicable 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
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.
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