A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.
- Conditions
- Transforaminal Lumbar Interbody Fusion Surgery
- Registration Number
- NCT06204900
- Lead Sponsor
- Retropsoas Technologies, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria:<br><br>• Undergoing a single-level or two-level TLIF between L2-S1<br><br>Exclusion Criteria:<br><br> - Requiring lumbar interbody fusion of greater than two levels<br><br> - Requiring TLIF surgery only at the L5-S1 level<br><br> - Acute lumbar spine trauma requiring immediate intervention<br><br> - Previous cervical stenosis surgery or lumbar fusion surgery at the level of interest<br><br> - BMI > 40 kg/m2<br><br> - Currently smoking<br><br> - Grade of weakness of < 4/5 in a lower extremity muscle<br><br> - Peripheral vascular disease or peripheral neuropathy<br><br> - Allergy or contraindication to propofol<br><br> - Lower extremity amputation<br><br> - Significant lower extremity edema noted on clinical exam<br><br> - History of drug or alcohol abuse<br><br> - High degrees of somatization on clinical or psychological evaluation<br><br> - Presence of a personality disorder or major psychiatric illness<br><br> - Greater than 12 months of disability or not working secondary to medical condition<br><br> - HbA1C >7.0% during pre-admission testing<br><br> - Active systemic bacterial or fungal infection or infection at operative site noted<br> during pre-operative physical exam<br><br> - Current treatment with chemotherapy, radiation, immunosuppression or chronic steroid<br> therapy<br><br> - Pregnant, or plans on becoming pregnant in the near future<br><br> - History of allergy to titanium, platinum, PEEK or silico
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of patients that experience an Adverse Device Effect (ADE);Ability of EARP System to alert the surgeon to nerve irritation during surgery compared to standard IONM monitoring techniques
- Secondary Outcome Measures
Name Time Method Evaluate the specificity and sensitivity of alerts to neurological deficits.;Assess monitorability of muscles/nerves;Assess the change from baseline to end of surgery for each muscle and modality