Intermittent Claudication, Lumbar Spinal Stenosis
Conditions
Brief summary
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.
Detailed description
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.
Interventions
DEVICEX-STOP® IPD® Device
Implantation of interspinous process spacer to treat lumbar spinal stenosis
DEVICESuperion™ Interspinous Spacer
Implantation of interspinous process spacer to treat lumbar spinal stenosis
Sponsors
VertiFlex, Incorporated
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female subjects ≥ 45 years of age * Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart) * Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal) * Must be able to sit for 50 minutes without pain and to walk 50 feet or more
Exclusion criteria
* Axial back pain only * Fixed motor deficit * Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device * Unremitting pain in any spinal position * Significant peripheral neuropathy or acute denervation secondary to radiculopathy * Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention * Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation * Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips * Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4) * Spondylolysis (pars fracture) * Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2 * Insulin-dependent diabetes mellitus * Prior surgery of the lumbar spine * Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction) * Infection in the disc or spine, past or present * Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease * Tumor in the spine or a malignant tumor except for basal cell carcinoma * Involved in pending litigation of the spine or worker's compensation related to the back
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Clinically Significant Improvement in Outcomes | Baseline and 24 months | Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following: * At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) \[validated, condition-specific patient-reported questionnaire that captures data in three distinct domains\] * Improvement in physical function by ≥0.5 points * Improvement in symptom severity by ≥0.5 points * Satisfied or somewhat satisfied as defined by a score of ≤ 2.5 points on the patient satisfaction domain * No re-operations, revisions, removals or supplemental fixation at the index level(s) * No major implant- or procedure-related complications: * No dislodgement, migration, or deformation * No new or persistent worsened neurological deficit at the index level * No spinous process fractures * No deep infection, death, or other permanent device attributed disability * No clinically significant confounding treatments: * No epidural injections or nerve block proc |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 - Study Treatment Superion™ Interspinous Spacer | 190 |
| 2 - Active Control Treatment X-STOP® IPD® Device | 201 |
| Total | 391 |
Baseline characteristics
| Characteristic | 1 - Study Treatment | 2 - Active Control Treatment | Total |
|---|---|---|---|
| Age, Customized | 66.9 years STANDARD_DEVIATION 9.4 | 66.2 years STANDARD_DEVIATION 10.2 | 66.5 years STANDARD_DEVIATION 9.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 11 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 185 Participants | 190 Participants | 375 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 80 Participants | 72 Participants | 152 Participants |
| Sex: Female, Male Male | 110 Participants | 129 Participants | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 190 | 6 / 201 |
| other Total, other adverse events | 82 / 190 | 100 / 201 |
| serious Total, serious adverse events | 113 / 190 | 117 / 201 |
Outcome results
Primary
Percentage of Subjects With Clinically Significant Improvement in Outcomes
Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following: * At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) \[validated, condition-specific patient-reported questionnaire that captures data in three distinct domains\] * Improvement in physical function by ≥0.5 points * Improvement in symptom severity by ≥0.5 points * Satisfied or somewhat satisfied as defined by a score of ≤ 2.5 points on the patient satisfaction domain * No re-operations, revisions, removals or supplemental fixation at the index level(s) * No major implant- or procedure-related complications: * No dislodgement, migration, or deformation * No new or persistent worsened neurological deficit at the index level * No spinous process fractures * No deep infection, death, or other permanent device attributed disability * No clinically significant confounding treatments: * No epidural injections or nerve block proc
Time frame: Baseline and 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 - Study Treatment | Percentage of Subjects With Clinically Significant Improvement in Outcomes | 52.7 percentage of subjects |
| 2 - Active Control Treatment | Percentage of Subjects With Clinically Significant Improvement in Outcomes | 50.2 percentage of subjects |