Postmarket Registry for Evaluation of the Superion® Spacer
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Device: Superion® Indirect Decompression System (IDS)
- 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
- Arm && Interventions
Group Intervention Description Superion® Indirect Decompression System (IDS) Superion® Indirect Decompression System (IDS) Superion® Indirect Decompression System (IDS) - Interspinous Spacer
- 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
Trial Locations
- Locations (65)
Spine Institute of North America, LLC
🇺🇸East Windsor, New Jersey, United States
Ainsworth Institute of Pain Management
🇺🇸New York, New York, United States
Pain Medicine Associates
🇺🇸Fountain Valley, California, United States
Southwest Florida Pain Center
🇺🇸Port Charlotte, Florida, United States
Pain Management Center of Paducah, KY
🇺🇸Paducah, Kentucky, United States
Upstate Orthopedics
🇺🇸East Syracuse, New York, United States
The Spine and Nerve Center of Saint Francis Hospital
🇺🇸Charleston, West Virginia, United States
Relieve Pain Center
🇺🇸San Diego, California, United States
Paul Kim MD Pain Management
🇺🇸San Diego, California, United States
Cincinnati Comprehensive Pain Center
🇺🇸Cincinnati, Ohio, United States
Performance Pain and Sports Medicine
🇺🇸Houston, Texas, United States
Advanced Spine and Pain Center
🇺🇸San Antonio, Texas, United States
Evolve Restorative Center
🇺🇸Santa Rosa, California, United States
The Spine Center of Southeast Georgia
🇺🇸Brunswick, Georgia, 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
Valley Pain Management
🇺🇸Fresno, California, United States
Pain Consultants of San Diego
🇺🇸La Mesa, California, United States
Pain Consultants of San Diego- Poway
🇺🇸Poway, California, United States
Newport Beach Headache & Pain
🇺🇸Newport Beach, California, United States
Remedy Pain Solutions, Inc.
🇺🇸Marina Del Rey, California, United States
San Diego Comprehensive Pain Management Center
🇺🇸San Diego, California, United States
Innovative Pain Treatment Solutions
🇺🇸Temecula, California, United States
Front Range Pain Medicine
🇺🇸Fort Collins, Colorado, United States
Intergrated Pain Management Medical Group, Inc.
🇺🇸Walnut Creek, California, United States
Source Healthcare
🇺🇸Santa Monica, California, United States
Holy Cross Interventional Spine and Pain Medicine
🇺🇸Fort Lauderdale, Florida, United States
International Spine Pain & Performance Center
🇺🇸Washington, District of Columbia, United States
Southeast Spine Associates
🇺🇸Fort Lauderdale, Florida, United States
The Orthopaedic & Sports Medicine Center
🇺🇸Trumbull, Connecticut, United States
Jacksonville Spine Center
🇺🇸Jacksonville, Florida, United States
Florida Pain Institute
🇺🇸Merritt Island, Florida, United States
Jupiter Interventional Pain Management
🇺🇸Jupiter, Florida, United States
Florida Pain Management Associates
🇺🇸Sebastian, Florida, United States
Georgia Pain and Spine Care
🇺🇸Newnan, Georgia, United States
AMITA Health Bolingbrook Pain Management Center
🇺🇸Bolingbrook, Illinois, United States
Rush University Medical Center Department of Anesthesiology
🇺🇸Chicago, Illinois, United States
Kansas University Medical Center
🇺🇸Kansas City, Kansas, United States
AXIS Spine Center
🇺🇸Coeur d'Alene, Idaho, United States
Neuroscience Research Center, LLC
🇺🇸Overland Park, Kansas, United States
Pain Management Associates
🇺🇸Lee's Summit, Missouri, United States
Columbia Interventional Pain Center
🇺🇸Columbia, Missouri, United States
Comprehensive and Interventional Pain Management
🇺🇸Henderson, Nevada, United States
Advanced Pain Specialists
🇺🇸Reno, Nevada, United States
Pain and Wellness
🇺🇸Cambridge, Massachusetts, United States
Center for Pain Control at Jasper Ambulatory Surgical Center
🇺🇸Brick, New Jersey, United States
Premier Pain Center
🇺🇸Shrewsbury, New Jersey, United States
Pain Management at Garden State Medical Center
🇺🇸Whiting, New Jersey, United States
University Clinical Research Center
🇺🇸Somerset, New Jersey, United States
Dayton Outpatient Center
🇺🇸Dayton, Ohio, United States
North Lake Pain Consultants
🇺🇸Conroe, Texas, United States
Performance Spine & Sports Physicians, PC
🇺🇸East Norriton, Pennsylvania, United States
Summit Medical Center
🇺🇸Edmond, Oklahoma, United States
Center for Interventional Pain & Spine
🇺🇸Exton, Pennsylvania, United States
SC Pain and Spine
🇺🇸Murrells Inlet, South Carolina, United States
Precision Spine Care
🇺🇸Tyler, Texas, United States
Southwest Spine and Pain
🇺🇸Saint George, Utah, United States
Fondren Orthopedic Group, LLC
🇺🇸Kingwood, Texas, United States
Advanced Pain Management
🇺🇸Greenfield, Wisconsin, United States
California Orthopedics & Spine
🇺🇸Larkspur, California, United States
(ACT) Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham, Alabama, United States
Tampa Pain Relief Center, Inc.
🇺🇸Tampa, Florida, United States
Lake Nona Medical Arts
🇺🇸Orlando, Florida, United States