The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode

Condition(s) studied

Investigational drug(s) / intervention(s)

Device: Nerve Cuff and Retractor System: Endoscopic Assisted Retropsoas (EARP) Nerve Cuff Electrode and an EARP Retractor system to safely monitor lumbar nerve root activity and function during standard interbody fusion surgeries.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Radiographic measurements prior to surgery and at follow-up visits — From enrollment until the end of follow-up at 12 months
  Radiographic measurements including X-Ray, CT Scans, and MRIs if available
• To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries — From surgery until the end of follow up at 12 months
  Adverse Device Events and surgical complications due to the devices

Trial sites (3)