Status:
COMPLETED
MMG vs. EMG for Cortical Breach Detection
Lead Sponsor:
Francis Farhadi
Collaborating Sponsors:
DePuy Synthes
Conditions:
Low Back Disorder
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having...
Eligibility Criteria
Inclusion
- scheduled to undergo a one-, two-, or three-level posterolateral spinal fusion surgery using Depuy Synthes Expedium pedicle screw instrumentation.
- over the age of 18 years old
- unresponsive to conservative care for a minimum of 6 months
- psychosocially, mentally, and physically able to fully consent and comply with this protocol
Exclusion
- preexisting medical condition or comorbidity that makes them a poor candidate
- open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis
- requires medications that may interfere with bone or soft tissue healing
- active local or systemic infection
- metal sensitivity/foreign body sensitivity
- implanted pacemaker
- morbidly obese, defined as a body mass index (BMI) greater than 45
- osteoporosis
- involved in or planning to engage in litigation or receiving Workers Compensation related to neck or back pain.
Key Trial Info
Start Date :
August 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05352048
Start Date
August 2 2022
End Date
November 6 2024
Last Update
August 19 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536