Spinal Stenosis, Lumbar Region, With Neurogenic Claudication
Conditions
Brief summary
Prospective, multicenter, randomized controlled clinical study examining functional improvement in lumbar spinal stenosis (LSS) patients with neurogenic claudication who are treated with the MILD procedure plus conventional medical management (CMM) compared to those treated with CMM alone, as the control. Subjects in the control group are able to crossover and receive MILD after completion of 12-month follow-up. The study will provide objective functional improvement data for patients treated with the mild Procedure as first-line therapy in a real-world setting.
Detailed description
The study will follow participants treated in the MILD plus CMM group and crossover participants for up to 5 years on annual bases.
Interventions
DEVICEMILD 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. Other Name: MILD lumbar decompression
CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Sponsors
Vertos Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients experiencing neurogenic claudication symptoms for at least 3 months duration. * LSS with neurogenic claudication * 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. * Patients with comorbid conditions commonly associated with spinal stenosis, such as osteophytes, facet hypertrophy, minor spondylolisthesis (Grade I without instability), foraminal stenosis, and/or disk protrusion may be included unless the treating physician has determined that the condition is too advanced. * Stable opioid intake with no change during 30 days prior to enrollment. * Available to complete all follow-up visits.
Exclusion criteria
* ODI Score \< 31 (0-100 ODI Scale). * NPRS Score \< 5 (0-10 NPRS Scale). * Lumbar epidural injections during eight weeks prior to study enrollment. * Baseline analgesic medication greater than 90 milligram morphine equivalent (MME). * Prior surgery at the same treatment level. * Previously received interspinous spacer at the same treatment level. * Previously received intradiscal procedure at the same treatment level. * Previously received vertebral augmentation procedure at the same treatment level. * Previously received the MILD procedure at the same treatment level. * Received radiofrequency ablation at the same or the adjacent levels within 6 months prior to study enrollment. * History of spinal fractures with current related pain symptoms. * Grade II or higher spondylolisthesis. * 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.). * 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. * Previously randomized and/or treated in this clinical study. * Epidural lipomatosis (if it is deemed to be a significant contributor of canal narrowing by the physician). * On (or pending) Workman's Compensation or known to be considering litigation associated with back pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Oswestry Disability Index (ODI) | Mean Change in Oswestry Disability Index (ODI) baseline to 12 month | Oswestry Disability Index (ODI) is a widely-used validated questionnaire use to measure a patient's functional disability. The total score ranges from 0 (no disability) - 100 (complete disability). Score categories: 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), 81-100 (bed bound or have an exaggerating). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MILD With CMM The MILD procedure is an image-guided minimally-invasive lumbar decompression with conventional medical managment
MILD 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.
Other Name: MILD lumbar decompression
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections. | 77 |
| CMM Alone Patient in the CMM alone group can have physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
Conventional Medical Management (CMM): CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections. | 78 |
| Total | 155 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Missed Visit | 1 | 2 |
| Overall Study | Not treated | 5 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | MILD With CMM | CMM Alone | Total |
|---|---|---|---|
| Age, Continuous | 64.7 Years STANDARD_DEVIATION 7.4 | 66.8 Years STANDARD_DEVIATION 7.5 | 65.7 Years STANDARD_DEVIATION 7.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 44 Participants | 45 Participants | 89 Participants |
| Sex: Female, Male Male | 33 Participants | 33 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 77 | 0 / 78 |
| other Total, other adverse events | 0 / 77 | 0 / 78 |
| serious Total, serious adverse events | 8 / 77 | 7 / 78 |
Outcome results
Primary
Mean Change in Oswestry Disability Index (ODI)
Oswestry Disability Index (ODI) is a widely-used validated questionnaire use to measure a patient's functional disability. The total score ranges from 0 (no disability) - 100 (complete disability). Score categories: 0-20 (minimal disability), 21-40 (moderate disability), 41-60 (severe disability), 61-80 (crippling back pain), 81-100 (bed bound or have an exaggerating).
Time frame: Mean Change in Oswestry Disability Index (ODI) baseline to 12 month
Population: ODI Outcome Measure Mean Improvement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MILD With CMM | Mean Change in Oswestry Disability Index (ODI) | 16.1 score on a scale | Standard Deviation 19 |
| CMM Alone | Mean Change in Oswestry Disability Index (ODI) | 2.0 score on a scale | Standard Deviation 11.7 |