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
Retropsoas Technologies, LLC
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.
Description
This multi-center post-marketing study will include consecutive patients who meet eligibility criteria, are scheduled to undergo a LIF procedure using the EARP Interbody System and EARP Nerve Cuff Electrode, and agree to participate. The study will include patients deemed appropriate for the procedure per the site's judgment, which may include patients with off-label use of the devices. Patients who consent to study participation and meet study criteria will undergo surgery according to site standard procedure. The EARP Nerve Cuff Electrode will be used to monitor nerve roots during surgery. R…
Eligibility
- Age range
- 22–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Undergoing LIF between L2-S1 Exclusion Criteria: * BMI \>40 kg/m2 * Pregnant or plans on becoming pregnant in the near future * Surgery requires combination of EARP with another lumbar interbody fusion technique (PLIF, TLIF, ALIF, OLIF, LLIF) or posterolateral fusion at another level * History of lumbar interbody pseudoarthrosis at planned operative level * Lumbar spondylolisthesis ≥ grade 3 * Osteoporotic vertebral compression fracture treated or untreated at planned operative site * History of lumbar spinal metastasis * Acute lumbar spine trauma requiring immediate i…
Interventions
- DeviceDevice: 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.
Locations (3)
- Northwell/PhelpsSleepy Hollow, New York
- Rothman Orthopaedic InstitutePhiladelphia, Pennsylvania
- Alleghany Health NetworkPittsburgh, Pennsylvania