Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Conditions
Keywords
Lumbar Spinal Stenosis, Spinal Stenosis, Neurogenic Claudication
Brief summary
Study Objective: To compare patient outcomes following treatment with either the MILD procedure or epidural steroid injections (ESIs) in patients with painful lumbar spinal stenosis exhibiting neurogenic claudication and having verified ligamentum flavum hypertrophy as a contributing factor.
Interventions
PROCEDUREMILD Procedure
The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
Injection of epidural steroids into the lumbar spine
Sponsors
Vertos Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 65 years or older and a Medicare beneficiary. 2. Patients experiencing neurogenic claudication symptoms for at least 3 months duration which has failed to respond or poorly responded to physical therapy, home exercise programs, and oral analgesics. 3. LSS with neurogenic claudication diagnosed via: 1. Symptomatic diagnosis and 2. Radiologic evidence of LSS with unilateral or bilateral ligamentum flavum \>2.5mm confirmed by pre-op MRI or CT performed within 12 months of baseline visit. 4. Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis, foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced. 5. Available to complete 6 month and one year follow-up visits.
Exclusion criteria
1. ODI Score \< 31 (0-100 ODI Scale). 2. NPRS Score \< 5 (0-10 NPRS Scale). 3. Prior surgery at any treatment level. 4. History of recent spinal fractures with current related pain symptoms. 5. Patients with Grade III or higher spondylolisthesis. 6. Motor deficit or disabling back and/or leg pain from causes other than LSS neurogenic claudication (e.g., acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). 7. Unable to walk ≥ 10 feet unaided before being limited by pain. In this context, 'unaided' means without the use of a cane, walker, railing, wall, another person or any other means of walking assistance. 8. Patients previously randomized and/or treated in this clinical study. 9. Patients that have previously received the MILD procedure. 10. ESI during eight weeks prior to study enrollment. 11. Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician). 12. On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months | 12 months | Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months | 12 months | Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold. |
| Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | 12 months | Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MILD Image guided minimally-invasive lumbar decompression
Minimally Invasive Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue. | 149 |
| Epidural Steroid Injection (ESI) An epidural steroid injection (ESI) is a combination of a corticosteroid with a local anesthetic pain relief medicine.
Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine | 153 |
| Total | 302 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not treated | 6 | 22 |
Baseline characteristics
| Characteristic | Epidural Steroid Injection (ESI) | Total | MILD |
|---|---|---|---|
| Age, Continuous | 75.0 Years STANDARD_DEVIATION 7 | 75.3 Years STANDARD_DEVIATION 7 | 75.6 Years STANDARD_DEVIATION 7 |
| NPRS | 7.8 units on a scale STANDARD_DEVIATION 1.3 | 7.8 units on a scale STANDARD_DEVIATION 1.4 | 7.7 units on a scale STANDARD_DEVIATION 1.4 |
| ODI | 51.7 units on a scale STANDARD_DEVIATION 12 | 52.3 units on a scale STANDARD_DEVIATION 12.4 | 53.0 units on a scale STANDARD_DEVIATION 12.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 153 Participants | 302 Participants | 149 Participants |
| Sex: Female, Male Female | 95 Participants | 170 Participants | 75 Participants |
| Sex: Female, Male Male | 58 Participants | 132 Participants | 74 Participants |
| ZCQ Physical Function | 2.8 units on a scale STANDARD_DEVIATION 0.4 | 2.8 units on a scale STANDARD_DEVIATION 0.5 | 2.9 units on a scale STANDARD_DEVIATION 0.5 |
| ZCQ Symptom Severity | 3.5 units on a scale STANDARD_DEVIATION 0.6 | 3.5 units on a scale STANDARD_DEVIATION 0.6 | 3.5 units on a scale STANDARD_DEVIATION 0.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 149 | 0 / 153 |
| other Total, other adverse events | 2 / 149 | 2 / 153 |
| serious Total, serious adverse events | 18 / 149 | 13 / 153 |
Outcome results
Primary
Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months
Proportion of ODI Responders from baseline to one year follow-up in the treatment group versus the proportion of ODI Responders from baseline to one year follow-up in the control group. ODI Responders are defined as those patients achieving the validated Minimal Important Change in ODI score from baseline to follow-up as a clinically significant efficacy threshold.
Time frame: 12 months
Population: Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimally Invasive Lumbar Decompression (MILD) | Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months | 83 Participants |
| Epidural Steroid Injection (ESI) | Number of Participants Who Achieved a Clinically Significant Improvement in the Oswestry Disability Index at 12 Months | 35 Participants |
Secondary
Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months
Proportion of NPRS Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Time frame: 12 months
Population: Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minimally Invasive Lumbar Decompression (MILD) | Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months | 82 Participants |
| Epidural Steroid Injection (ESI) | Number of Participants Who Acheived a Clinical Significant Improvement in the Numeric Pain Rating Scale (NPRS) at 12 Months | 35 Participants |
Secondary
Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months
Proportion of ZCQ Responders from baseline to one year follow-up in each of the two treatment groups using validated Minimal Important Change value as the clinically significant efficacy threshold.
Time frame: 12 months
Population: Six participants in the MILD and 22 in the ESI group did not receive study treatment, therefore 143/149 MILD participants and 129/153 ESI participants were analyzed for outcome.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Minimally Invasive Lumbar Decompression (MILD) | Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | Symptom Severity | 74 Participants |
| Minimally Invasive Lumbar Decompression (MILD) | Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | Physical Function | 63 Participants |
| Minimally Invasive Lumbar Decompression (MILD) | Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | Patient Satisfaction | 88 Participants |
| Epidural Steroid Injection (ESI) | Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | Symptom Severity | 41 Participants |
| Epidural Steroid Injection (ESI) | Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | Physical Function | 23 Participants |
| Epidural Steroid Injection (ESI) | Number of Participants Who Achieved a Clinically Significant Improvement in the Zurich Claudication Questionnaire (ZCQ) at 12 Months | Patient Satisfaction | 43 Participants |