Lumbar Spinal Stenosis
Conditions
Keywords
Spinal Stenosis, Lumbar Spinal Stenosis, Laminotomy, Laminectomy, Spine Surgery
Brief summary
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for lumbar spinal stenosis. In this study, patient-reported outcomes over a 3 month period following treatment will be collected by the investigator. Periodic surveys for each study subject's pain, functional status, quality of life and physical examination will track outcomes following MILD™ treatment.
Detailed description
The Vertos MILD™ devices are used for image-guided Minimally Invasive Lumbar Decompression, referred to as the MILD™ procedure. This percutaneous procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. Lumbar decompression is performed through the removal of tissue and bone, where indicated. All procedures are conducted in accordance with the product labeling and indications for use. A minimum of ten up to a maximum of twenty-five adult patients will be enrolled and followed for a period of up to 6 months. Patients with symptomatic lumbar spinal stenosis who meet the study enrollment criteria will be offered the MILD™ procedure as an alternative to surgery or continued standard non-surgical medical management.
Interventions
DEVICEMinimally Invasive Lumbar Decompression (MILD™)
The arthroscopic devices in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
Sponsors
Vertos Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Symptomatic lumbar spinal stenosis (LSS) primarily caused by dorsal element hypertrophy. 2. Prior failure of conservative therapy. 3. Radiologic evidence of LSS (L3-L5), Ligamentum flavum \> 2.5 mm, confirmed by pre op MRI and/or CT. 4. Central canal cross sectional area \< 100mm2. 5. Anterior listhesis \< 2 - 3mm. 6. Able to walk at least 10 feet unaided before being limited by pain. 7. Available to complete 12 weeks of follow-up. 8. A signed Informed Consent Form is obtained from the patient. 9. Adults ≥ 18 years of age.
Exclusion criteria
1. Prior surgery at intended treatment level. 2. History of recent spinal fractures with concurrent pain symptoms. 3. Disabling back or leg pain from causes other than LSS (e.g. acute compression fracture, metabolic neuropathy, or vascular claudication symptoms, etc.). 4. Significant disk protrusion or osteophyte formation. 5. Excessive facet hypertrophy. 6. Bleeding disorders and/or current use of anti coagulants. 7. Use of acetylsalicylic acid (ASA) and/or non-steroidal anti-inflammatory drug (NSAID) within 5 days of treatment. 8. Epidural steroids within prior three weeks. 9. Inability of the patient to lie prone for any reason with anesthesia support (e.g. chronic obstructive pulmonary disease (COPD), obesity, etc.). 10. Any potential wound healing pathologies that may compromise outcomes, including: diabetes, excessive smoking history, cancer, connective tissue diseases, recent spine radiation and severe COPD. 11. Dementia and/or inability to give informed consent. 12. Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). | Baseline and Six Months | Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value. |
| Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire | Baseline and Month 6 | Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability. |
| Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey. | Baseline and Six months | The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value. |
Countries
Canada
Participant flow
Recruitment details
Study enrolled between September 2008 and January 2009. Recruitment derived from patient pool of complex cases, all with confirmed presence of hypertrophic ligament, wait-listed for decompression laminectomy.
Participants by arm
| Arm | Count |
|---|---|
| Mild Percutaneous Lumbar Decompression The single group in this pilot study included ten patients treated for lumbar spinal stenosis of the central canal using the mild device kit to perform minimally invasive percutaneous decompression. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Mild Percutaneous Lumbar Decompression |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age Continuous | 62.9 years STANDARD_DEVIATION 12.84 |
| Region of Enrollment Canada | 10 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS).
Clinical relevance established by change of two points or more on a ten point scale where zero represents no pain and ten represents worst pain imaginable. Mean change from baseline to Month 6 was reported with a positive number representing the baseline value minus the 6 month value.
Time frame: Baseline and Six Months
Population: All available treated patients at six months post treatment. Mean change from baseline to Month 6 was reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild Percutaneous Lumbar Decompression | Changes in Back Pain as Measured by a 10-point Visual Analog Scale (VAS). | 3.3 units on a scale | Standard Deviation 2.95 |
Primary
Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire
Oswestry Disability Index (ODI) is used to measure permanent functional disability through a series of questions which characterize the disturbance of activities of daily living resulting from chronic back pain. The questionnaire is divided into 10 topics including pain intensity , personal care, lifting, walking, sitting, standing, sleeping, social life, traveling and employment/homemaking. Each topic is rated 0 (no pain or no limitation) to 5 (high pain or very limited physically). The worst possible score is 50 (100% disability) and best would be zero (0% disability), thus a higher ODI score indicates greater disability.
Time frame: Baseline and Month 6
Population: All treated patients having six month follow-up were included.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild Percutaneous Lumbar Decompression | Function as Measured Subjectively by the Oswestry Disability Index Patient Questionnaire | 19.4 units on a scale | Standard Deviation 22.73 |
Primary
Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey.
The 12-question SF-12v2 Health Survey is a validated generic measure of health status & outcomes, as opposed to one that targets a specific age, disease, or treatment group. The Physical Component Summary (PCS)takes into account the correlations among the Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), and Vitality (VT)SF-12v2 Health Survey scales to show the broad impact on PCS. Norm-based scoring is used so each scale has the same mean (50 points) and the same standard deviation (10 points) as the general US population in 1998. Scores below 50 indicate a decline in health status, with lower scores representing worse health status. Minimally Important Difference (MID) is a measure of true clinical relevance of a difference, with suggested MID for the Physical Component Summary (PCS) being 2 to 3 points. Change from baseline to 6 months is presented, where a positive value represents the 6 month value minus the baseline value.
Time frame: Baseline and Six months
Population: All available treated patients with six month follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mild Percutaneous Lumbar Decompression | Quality of Life as Measured by the PCS Subscale of the Short-form 12 Question (SF-12) Survey. | 6.14 units on a scale | 95% Confidence Interval 9.31 |