Lumbar Spinal Stenosis
Conditions
Keywords
Lumbar Spinal Stenosis, LSS, Chronic Pain, Leg Pain
Brief summary
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Detailed description
To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use
Interventions
DEVICESuperion™ IDS device
The Superion™ IDS is a minimally-invasive spinal implant that treats LSS symptoms by limiting extension at the symptomatic level that compresses the neural elements and is designed for percutaneous surgical placement.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 45 years of age or older when written informed consent is obtained * Persistent leg/buttock/groin pain, with or without back pain that is consistently 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 access), and the nerve root canal (foraminal). * Subject signed a valid, IRB-approved informed consent form (ICF) provided in English. * Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups. * Able to independently read and complete all questionnaires and assessments provided in English Key
Exclusion criteria
* Axial back pain only. * Fixed motor deficit in lower extremity(ies) due to LSS. * Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation, spinal tumor) * Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of success at the 24-month follow-up visit | 24-Months | Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit: 1. Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ * ≥ 0.5-point improvement in physical function * ≥ 0.5-point improvement in symptom severity * ≤ 2.5 point on patient satisfaction domain 2. No reoperations, removals, revisions, or supplemental fixation at the index level(s) 3. No major implant or procedure-related complications * no dislodgement, migration, or device deformation * no new or persistent worsened neurological deficit at the index level† * no unhealed spinous process fractures † Defined as a serious adverse event wherein there is any new/worsening of motor or sensory function at 12 months, compared to baseline, which persists to 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction: VertiFlex® Patient Satisfaction Survey | 24-, 36-, 48- and 60-Months | Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale |
Countries
United States
Contacts
STUDY_DIRECTORNatalie Bloom Lyons
Boston Scientific Corporation
Outcome results
None listed