Postmarket Registry for Evaluation of the Superion® Spacer
- Conditions
- Lumbar Spinal Stenosis
- Registration Number
- NCT04087811
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® Indirect Decompression System (IDS).
- Detailed Description
To gather evidence documenting the performance and clinical outcomes associated with treatment of moderate degenerative lumbar spinal stenosis using the Superion® IDS in patients ≥45 years of age suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis at one or two contiguous levels from L1 to L5.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1674
- male and female patients ≥45 years of age
- symptoms of neurogenic intermittent claudication and a confirmed diagnosis of moderate degenerative lumbar stenosis at one or two contiguous levels from L1 to L5
- meeting the labeled indications for use of the Superion® Indirect Decompression System (IDS)
- not contraindicated as described in the labeled indications for use
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vertiflex® Patient Satisfaction Survey 12 Month Follow-Up Visit Percentage of patients reporting satisfied or somewhat satisfied with treatment during study follow up was calculated.
Patients chose one of the following options to describe their overall satisfaction with their treatment (1) Satisfied (2) Somewhat Satisfied (3) Somewhat Dissatisfied (4) Dissatisfied. The percentage of patients who reported (1) Satisfied or (2) Somewhat satisfied were included and calculated in the analysis. Maximum is 100% of patients reported being satisfied and minimum is 0%.
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (65)
(ACT) Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
HOPE Research Institute
🇺🇸Scottsdale, Arizona, United States
NuVation Pain Group
🇺🇸Buena Park, California, United States
Comprehensive Pain Physicians
🇺🇸Burbank, California, United States
Coastal Pain and Spinal Diagnostics
🇺🇸Carlsbad, California, United States
Pain Medicine Associates
🇺🇸Fountain Valley, California, United States
Valley Pain Management
🇺🇸Fresno, California, United States
Pain Consultants of San Diego
🇺🇸La Mesa, California, United States
California Orthopedics & Spine
🇺🇸Larkspur, California, United States
Remedy Pain Solutions, Inc.
🇺🇸Marina Del Rey, California, United States
Scroll for more (55 remaining)(ACT) Alabama Clinical Therapeutics, LLC🇺🇸Birmingham, Alabama, United States