MMG vs. EMG for Cortical Breach Detection

Low Back Disorder Clinical Trial

Official title:

Prospective Evaluation of Mechanomyography Versus Triggered Electromyography for Intraoperative Assessment of Cortical Breaches During Instrumented Lumbar Spine Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05352048
• Other study ID #: 76122
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: March 2025

Study information

• Verified date: August 2023
• Source: University of Kentucky
• Contact: H. Francis Farhadi, MD, PhD
• Phone: 859-323-5661
• Email: Francis.Farhadi[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 lower back surgery requiring hardware. Both MMG and EMG are devices approved by the FDA to detect the location of nerves during surgery so they can be avoided. The results from both tests will be compared to one another to determine if one is better at accurately locating nerves than the other.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Low Back Disorder

Intervention

Device:
• Triggered Electromyography
Triggered electromyography will be used during surgery to detect nerve impingement by pedicle screws used for spinal fusion. Threshold stimulation data from the device will be recorded.
• Mechanomyography
SENTIO MMG ball tip probe will be used during surgery to detect nerve impingement by pedicle screws used for spinal fusion. Threshold stimulation data from the device will be recorded, and the accuracy compared to the data from the triggered electromyography.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
H. Francis Farhadi	DePuy Synthes

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of Pedicle Screw Trajectories	Patients with successful pedicle screw trajectories determined by the percentage of patients with A/B or C/D/E breaches.; Grade A - No cortical breach (0 mm); Grade B - Pedicle cortical breach < 2 mm; Grade C - Pedicle cortical breach = 2 to < 4 mm; Grade D - Pedicle cortical breach = 4 to < 6 mm; Grade E - Pedicle cortical breach = 6 mm	1 hour
Secondary	Change in the Numeric Rating Scale (NRS) Questionnaire for pain.	This survey is used to assess pain experienced by the subject and the severity of the pain. Types of pain include numbness, pins and needles, dull aching, burning sensation, muscle cramps, and stabbing pain. Pain severity is rated on a scale of 0-10 where 0 is no pain and 10 is the worst pain imaginable. Pain is assessed in the neck, back, arms, and legs.	6 weeks and 3 months after surgery
Secondary	Change in the Oswestry Disability Index version 2.1A	This survey is used to quantify disability for low back pain. There are five disability categories ranging from minimally disabled to crippled. The appropriate disability category is determined by the sum of the subjects points divided by the total possible points(50) times 100. This yields a % disabled score and this % determines the appropriate category designation. 0% is equated with no disability and 100% is the maximum disability possible.	6 weeks and 3 months after surgery
Secondary	Change in the PROMIS Global-10	This questionnaire is a 10 item patient reported tool used to quantify the patients general healthcare related quality of life. It assesses both physical and mental health and is scored as a percentage. Scores closer to 100% report a better quality of life than those who score lower.	6 weeks and 3 months after surgery
Secondary	Change in the Short-From (SF-36) Health Survey	This survey quantifies how a patient feels about their health, and how well they are able to do common activities. This survey has 9 domains that assess the patients functional ability. The domains are scored as percentages from 0%-100% with 0% being severely limited and 100% being no deficits.	6 weeks and 3 months after surgery
Secondary	Hospital Readmission at 30 days	Percent of patients undergoing hospital readmission 30 days following the procedure.	30 days
Secondary	Hospital Readmission at 90 days	Percent of patients undergoing hospital readmission 90 days following the procedure.	90 days