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
Starting soon
Conditions studied: Transforaminal Lumbar Interbody Fusion Surgery
In brief
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.
Key facts
- Study ID
- NCT07020000
- Run by
- Retropsoas Technologies, LLC
- People needed
- 120
- Starts
- 2025-08-30
- Expected to finish
- 2027-09-30
- Last updated by the study team
- 2025-06-13
Who can join
Age: 22 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Undergoing LIF between L2-S1
You may not qualify if…
- 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
Where it is running
- Northwell/Phelps — Sleepy Hollow, New York, United States
- Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States
- Alleghany Health Network — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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