A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Device: Superion™ IDS device
- Registration Number
- NCT04192591
- Lead Sponsor
- Boston Scientific Corporation
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 214
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Superion™ IDS device Superion™ IDS device Superion™ Indirect Decompression System (IDS)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Related Research Topics
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Trial Locations
- Locations (27)
Coastal Research Institute, LLC
🇺🇸Carlsbad, California, United States
MarinHealth Spine Institute
🇺🇸Larkspur, California, United States
Vitamed Research
🇺🇸Rancho Mirage, California, United States
Pacific Research Institute
🇺🇸Santa Rosa, California, United States
IPM Medical Group Inc.
🇺🇸Walnut Creek, California, United States
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
The Orthopaedic Institute
🇺🇸Gainesville, Florida, United States
Florida Pain Management
🇺🇸Sebastian, Florida, United States
Alliance Spine and Pain Centers
🇺🇸Atlanta, Georgia, United States
Centurion Spine and Pain
🇺🇸Waycross, Georgia, United States
North Idaho Day Surgery
🇺🇸Post Falls, Idaho, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Ascension Alexian Brothers
🇺🇸Elk Grove Village, Illinois, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
Neuroscience Research Center, LLC
🇺🇸Overland Park, Kansas, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Michigan Pain Specialists
🇺🇸Ypsilanti, Michigan, United States
Weill Cornell Medical University
🇺🇸New York, New York, United States
Pacific Sports and Spine, LLC
🇺🇸Eugene, Oregon, United States
Spinal Diagnostics
🇺🇸Tualatin, Oregon, United States
Center for Interventional Pain and Spine
🇺🇸Lancaster, Pennsylvania, United States
SC Pain and Spine Specialists
🇺🇸Murrells Inlet, South Carolina, United States
Central Texas Pain Institute
🇺🇸Killeen, Texas, United States
Precision Spine Care
🇺🇸Tyler, Texas, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
Northwest Pain Care
🇺🇸Spokane, Washington, United States
The Spine and Nerve Center of Saint Francis Hospital
🇺🇸Charleston, West Virginia, United States