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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Device: Nerve Cuff and Retractor System.
- Who it may be relevant to
- Registry conditions: Transforaminal Lumbar Interbody Fusion Surgery. Basic parameters: 22 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed 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. 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.
Interventions
- Device 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.
Primary outcome measures
- Radiographic measurements prior to surgery and at follow-up visits [Time frame: From enrollment until the end of follow-up at 12 months]
- To evaluate the safety of the EARP surgical technique and devices used during LIF surgeries [Time frame: From surgery until the end of follow up at 12 months]
Secondary outcome measures (3)
- Assess the ability of the EARP fusion system to reduce pain and restore function [Time frame: Baseline to final follow-up visit at 12 months]
- Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode [Time frame: During Surgery]
- Quantify health economic factors associated with the EARP fusion system for LIF procedures [Time frame: From surgery to end of follow up at 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Northwell/Phelps — Sleepy Hollow
- Rothman Orthopaedic Institute — Philadelphia
- Alleghany Health Network — Pittsburgh
Identifiers
NCT: NCT07020000 · EARP-2-1002