Lumbar Spinal Stenosis
Conditions
Brief summary
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct Decompression System or Sham Comparator Surgical Procedure in patients with lumbar spinal stenosis
Detailed description
Subjects suffering from symptoms of neurogenic intermittent claudication secondary to a radiographically-confirmed diagnosis of central canal stenosis, with or without mild or moderate lateral recess stenosis, at one or two levels from L1 to L5 who meet all inclusion/exclusion criteria, including ≥6 months of non-operative management. Patients included in the clinical investigation will return for follow-up visits at 1 week for safety evaluation, and at 6 weeks, 3 months, 6 months, 12 months, 18 months and 24 months post-treatment to collect data for evaluation of safety and effectiveness.
Interventions
DEVICETotalis
PROCEDUREComparator Surgical Procedure
Sponsors
VertiFlex, Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects greater than or equal to 55 years of age * Neurogenic intermittent claudication (NIC) symptoms defined generally as leg/buttock/ groin pain and/or paresthesias that are exacerbated with standing and walking and relieved by flexion * VAS leg symptom severity \>50 (in either leg) during episodes of neurogenic claudication * Subjects who are able to walk a minimum of 50 feet without experiencing NIC symptoms * Diagnosis of central canal spinal stenosis, with or without mild to moderate lateral recess stenosis, at one or two levels from L1-L5 with radiologic evidence * Subjects with persistent lumbar spinal stenosis symptoms that, during the course of the last year, have been unresponsive to a minimum of 6 months of conservative therapy
Exclusion criteria
* Significant back, buttock or leg pain from causes other than lumbar central canal stenosis * Axial back pain only * Severe foraminal stenosis at index level(s) and/or symptomatic foraminal stenosis at any lumbar level * Severe lateral recess stenosis * Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention * Prior decompressive surgery at index level (s) or fusion at any lumbar level * Epidural steroid or nerve block steroid injection at index level(s) within 6 weeks of baseline assessments * Spondylolisthesis (anterolisthesis or retrolisthesis) greater than grade 1 * Spondylolysis (pars fracture) * Significant degenerative lumbar scoliosis at index level(s) * Morbid obesity * Significant peripheral vascular disease * Active significant co-morbidity * Undergoing immunosuppressive therapy or long-term steroid use * Current spinal cord stimulator or implanted pain pump * Life expectancy less than 2 years * Evidence of substance abuse within the year * Involvement or potential involvement in litigation related to the spine or worker's compensation related to a back and/or leg issue
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Clinically Significant Improvement in Outcomes | Baseline and 6 Months | Where clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ) * Improvement in physical function by ≥ 0.5 points from baseline * Improvement in symptom severity by ≥ 0.5 points from baseline * Patient Satisfaction Score of \< 2.5 points And no interventions of the following nature through 6 months: * Re-operations or revisions at index level(s) intended to treat stenosis * Epidural steroid injection or selective nerve root block at index level(s) And no unblindings |
Countries
United States
Participant flow
Pre-assignment details
180 subjects enrolled; 12 withdrew, leaving 168 subjects randomized & treated.
Participants by arm
| Arm | Count |
|---|---|
| Totalis Totalis ™ Direct Decompression Procedure | 112 |
| Control Procedure Comparator Surgical Procedure | 56 |
| Total | 168 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Completed 6 Months | Lost to Follow-up | 2 | 1 |
| Modified Intent to Treat Population | Death | 1 | 0 |
| Modified Intent to Treat Population | Withdrawal by Subject | 6 | 5 |
Baseline characteristics
| Characteristic | Totalis | Control Procedure | Total |
|---|---|---|---|
| Age, Customized | 70.8 years STANDARD_DEVIATION 10.4 | 71.8 years STANDARD_DEVIATION 7.7 | 71.1 years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants | 54 Participants | 163 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 58 Participants | 36 Participants | 94 Participants |
| Sex: Female, Male Male | 54 Participants | 20 Participants | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 112 | 0 / 56 |
| other Total, other adverse events | 98 / 112 | 42 / 56 |
| serious Total, serious adverse events | 19 / 112 | 11 / 56 |
Outcome results
Primary
Percentage of Subjects With Clinically Significant Improvement in Outcomes
Where clinically significant improvement in outcomes is defined as improvement in any 2 of the 3 domains of the Zurich Claudication Questionnaire ( ZCQ) * Improvement in physical function by ≥ 0.5 points from baseline * Improvement in symptom severity by ≥ 0.5 points from baseline * Patient Satisfaction Score of \< 2.5 points And no interventions of the following nature through 6 months: * Re-operations or revisions at index level(s) intended to treat stenosis * Epidural steroid injection or selective nerve root block at index level(s) And no unblindings
Time frame: Baseline and 6 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Totalis | Percentage of Subjects With Clinically Significant Improvement in Outcomes | 56.3 percentage of subjects |
| Control Procedure | Percentage of Subjects With Clinically Significant Improvement in Outcomes | 56.0 percentage of subjects |