Status:
RECRUITING
A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.
Lead Sponsor:
Retropsoas Technologies, LLC
Conditions:
Transforaminal Lumbar Interbody Fusion Surgery
Eligibility:
All Genders
22-80 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery. The En...
Detailed Description
The application of traditional SSEPs and tcMEPs to lumbar nerve root monitoring during TLIF surgery is both challenging and problematic. When applied to lumbar nerve root monitoring, SSEPs and tcMEPs ...
Eligibility Criteria
Inclusion
- • Undergoing TLIF between L2-S1
Exclusion
- Requiring TLIF surgery only at the L5-S1 level
- Acute lumbar spine trauma requiring immediate intervention
- Allergy or contraindication to propofol
- Lower extremity amputation
- Significant lower extremity edema noted on clinical exam
- Current treatment with chemotherapy, radiation, or immunosuppression
- Pregnant, or plans on becoming pregnant in the near future
- History of allergy to titanium, platinum, aluminum, stainless steel, or silicon
Key Trial Info
Start Date :
June 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06204900
Start Date
June 7 2024
End Date
July 1 2025
Last Update
February 21 2025
Active Locations (2)
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1
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
2
Allegheny-Singer Research Institute
Pittsburgh, Pennsylvania, United States, 15212