Transforaminal Lumbar Interbody Fusion Surgery
Conditions
Keywords
Transforaminal Lumbar Interbody Fusion Surgery, TLIF, EARP, Retropsoas Technologies, LLC
Brief 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.
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
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.
Sponsors
Retropsoas Technologies, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 80 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the ability of the EARP fusion system to reduce pain and restore function | Baseline to final follow-up visit at 12 months | The Oswestry Disability Index (ODI) |
| Assess IONM data during procedure related to the effectiveness of the EARP Nerve Cuff Electrode | During Surgery | IONM data during surgical procedure |
| Quantify health economic factors associated with the EARP fusion system for LIF procedures | From surgery to end of follow up at 12 months | Health economic data including OR time, operative time, hospital length of stay, anesthetic technique, unilateral vs. bilateral fixation, bone graft choice |
Countries
United States
Contacts
Primary ContactMedical Director
Outcome results
None listed