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.

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. Radiographic imaging will document the fusion status and various disk space parameters, and the Oswestry Disability Index (ODI) will be used to assess function and pain. Data will be collected from standard site follow-up visits at 6 weeks, 3 months, 6 months, and 12 months after surgery. Economic data will be collected to quantify the economics of the EARP Interbody System for LIF procedures.

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 intervention
• Owestry Disability Index (ODI) 81-100%
• Presence of personality disorder or major psychiatric illness
• History of allergy to titanium, platinum, PEEK, aluminum, stainless steel or silicone
• Any additional factor that makes the patient an unsuitable candidate for the study in the opinion of the principal investigator

Any patient undergoing LIF between L2-S1and surgeon feels is a good candidate for the EARP Procedure

Individual participant data that underlie the results reported in publications, after deidentification (text, tables, figures, and appendices).

Beginning 9 months and ending 36 months following article publication.

Investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose.

For individual participant data meta-analysis.

Information can be accessed by contacting the Sponsor directly (contact info TBD)