Low Back Disorder
Conditions
Keywords
Lower back surgery, Lumbar fusion
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 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.
Interventions
DEVICETriggered 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.
DEVICEMechanomyography
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.
Sponsors
DePuy Synthes
Francis Farhadi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of Pedicle Screw Trajectories | 1 hour | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Oswestry Disability Index Version 2.1A | 3 months after surgery | 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. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\] |
| Change From Baseline in the PROMIS Global-10 | 3 months after surgery | 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. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\] |
| Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain. | 3 months after surgery | 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 back and legs. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\]. |
| Hospital Readmission at 30 Days | 30 days | Percent of patients undergoing hospital readmission 30 days following the procedure. |
| Hospital Readmission at 90 Days | 90 days | Percent of patients undergoing hospital readmission 90 days following the procedure. |
| Change in the Short-From (SF-36) Health Survey | 6 weeks and 3 months after surgery | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraoperative MMG vs EMG for Cortical Breach Detection Participants in this arm will be assessed with both MMG and EMG during their lower spine fusion surgery.
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. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | did not get EMG-MMG readings intraoperatively | 3 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Intraoperative MMG vs EMG for Cortical Breach Detection |
|---|---|
| Age, Continuous | 61.26 years STANDARD_DEVIATION 9.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 59 Participants |
| Region of Enrollment United States | 61 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 23 / 61 |
| serious Total, serious adverse events | 3 / 61 |
Outcome results
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
Time frame: 1 hour
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Intraoperative MMG vs EMG for Cortical Breach Detection | Success of Pedicle Screw Trajectories | Grade E | 2 Screws |
| Intraoperative MMG vs EMG for Cortical Breach Detection | Success of Pedicle Screw Trajectories | Grade A or B | 296 Screws |
| Intraoperative MMG vs EMG for Cortical Breach Detection | Success of Pedicle Screw Trajectories | Grade C | 5 Screws |
Secondary
Change From Baseline 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 back and legs. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\].
Time frame: 3 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intraoperative MMG vs EMG for Cortical Breach Detection | Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain. | NRS Back Pain | -3.80 score on a scale | Standard Deviation 3.22 |
| Intraoperative MMG vs EMG for Cortical Breach Detection | Change From Baseline in the Numeric Rating Scale (NRS) Questionnaire for Pain. | NRS Leg Pain | -4.15 score on a scale | Standard Deviation 3.41 |
Secondary
Change From Baseline 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. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\]
Time frame: 3 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intraoperative MMG vs EMG for Cortical Breach Detection | Change From Baseline in the Oswestry Disability Index Version 2.1A | -47.4 percentage of disability | Standard Deviation 34.2 |
Secondary
Change From Baseline 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. Changes reported as percentages using the formula \[(Average measure at 3 months - Average measure at baseline)/Average measure at baseline\]
Time frame: 3 months after surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intraoperative MMG vs EMG for Cortical Breach Detection | Change From Baseline in the PROMIS Global-10 | Mental Health | 14.6 percentage of quality of life | Standard Deviation 28 |
| Intraoperative MMG vs EMG for Cortical Breach Detection | Change From Baseline in the PROMIS Global-10 | Physical Health | 26.6 percentage of quality of life | Standard Deviation 38 |
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.
Time frame: 6 weeks and 3 months after surgery
Population: Survey data never collected due to redundancy and overlapping questions contained in the PROMIS-10 survey.
Secondary
Hospital Readmission at 30 Days
Percent of patients undergoing hospital readmission 30 days following the procedure.
Time frame: 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intraoperative MMG vs EMG for Cortical Breach Detection | Hospital Readmission at 30 Days | 3.28 percentage of participants |
Secondary
Hospital Readmission at 90 Days
Percent of patients undergoing hospital readmission 90 days following the procedure.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intraoperative MMG vs EMG for Cortical Breach Detection | Hospital Readmission at 90 Days | 1.64 Percentage of participants |