Postmarket Registry for Evaluation of the Superion® Spacer (PRESS)

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).

Study Overview

• Status: Completed
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 1674

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
      • (ACT) Alabama Clinical Therapeutics, LLC
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute
    • Scottsdale, Arizona, United States, 85018
      • Hope Research Institute
  • California
    • Buena Park, California, United States, 90621
      • Nuvation Pain Group
    • Burbank, California, United States, 91505
      • Comprehensive Pain Physicians
    • Carlsbad, California, United States, 92009
      • Coastal Pain and Spinal Diagnostics
    • Fountain Valley, California, United States, 92708
      • Pain Medicine Associates
    • Fresno, California, United States, 93720
      • Valley Pain Management
    • La Mesa, California, United States, 91942
      • Pain Consultants of San Diego
    • Larkspur, California, United States, 94939
      • California Orthopedics & Spine
    • Marina Del Rey, California, United States, 90292
      • Remedy Pain Solutions, Inc.
    • Newport Beach, California, United States, 92660
      • Newport Beach Headache & Pain
    • Poway, California, United States, 92064
      • Pain Consultants of San Diego- Poway
    • San Diego, California, United States, 92103
      • Relieve Pain Center
    • San Diego, California, United States, 92108
      • Paul Kim MD Pain Management
    • San Diego, California, United States, 92108
      • San Diego Comprehensive Pain Management Center
    • Santa Monica, California, United States, 90403
      • Source Healthcare
    • Santa Rosa, California, United States, 95403
      • Evolve Restorative Center
    • Temecula, California, United States, 92590
      • Innovative Pain Treatment Solutions
    • Walnut Creek, California, United States, 94598
      • Intergrated Pain Management Medical Group, Inc.
  • Colorado
    • Fort Collins, Colorado, United States, 80525
      • Front Range Pain Medicine
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • The Orthopaedic & Sports Medicine Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20006
      • International Spine Pain & Performance Center
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Southeast Spine Associates
    • Fort Lauderdale, Florida, United States, 33334
      • Holy Cross Interventional Spine and Pain Medicine
    • Jacksonville, Florida, United States, 32256
      • Jacksonville Spine Center
    • Jupiter, Florida, United States, 33477
      • Jupiter Interventional Pain Management
    • Merritt Island, Florida, United States, 32953
      • Florida Pain Institute
    • Orlando, Florida, United States, 32827
      • Lake Nona Medical Arts
    • Port Charlotte, Florida, United States, 33948
      • Southwest Florida Pain Center
    • Sebastian, Florida, United States, 32958
      • Florida Pain Management Associates
    • Tampa, Florida, United States, 33613
      • Tampa Pain Relief Center, Inc.
  • Georgia
    • Brunswick, Georgia, United States, 31525
      • The Spine Center of Southeast Georgia
    • Newnan, Georgia, United States, 30265
      • Georgia Pain and Spine Care
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83815
      • Axis Spine Center
  • Illinois
    • Bolingbrook, Illinois, United States, 60440
      • AMITA Health Bolingbrook Pain Management Center
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center Department of Anesthesiology
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
    • Overland Park, Kansas, United States, 66210
      • Neuroscience Research Center, LLC
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Pain Management Center of Paducah, KY
  • Massachusetts
    • Cambridge, Massachusetts, United States, 01960
      • Pain and Wellness
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Columbia Interventional Pain Center
    • Lee's Summit, Missouri, United States, 64086
      • Pain Management Associates
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive and Interventional Pain Management
    • Reno, Nevada, United States, 89511
      • Advanced Pain Specialists
  • New Jersey
    • Brick, New Jersey, United States, 08723
      • Center for Pain Control at Jasper Ambulatory Surgical Center
    • East Windsor, New Jersey, United States, 08520
      • Spine Institute of North America, LLC
    • Shrewsbury, New Jersey, United States, 07702
      • Premier Pain Center
    • Somerset, New Jersey, United States, 08873
      • University Clinical Research Center
    • Whiting, New Jersey, United States, 08759
      • Pain Management at Garden State Medical Center
  • New York
    • East Syracuse, New York, United States, 13057
      • Upstate Orthopedics
    • New York, New York, United States, 10022
      • Ainsworth Institute of Pain Management
  • Ohio
    • Cincinnati, Ohio, United States, 45014
      • Cincinnati Comprehensive Pain Center
    • Dayton, Ohio, United States, 45432
      • Dayton Outpatient Center
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Summit Medical Center
  • Pennsylvania
    • East Norriton, Pennsylvania, United States, 19403
      • Performance Spine & Sports Physicians, PC
    • Exton, Pennsylvania, United States, 19341
      • Center for Interventional Pain & Spine
  • South Carolina
    • Murrells Inlet, South Carolina, United States, 29576
      • SC Pain and Spine
  • Texas
    • Conroe, Texas, United States, 77340
      • North Lake Pain Consultants
    • Houston, Texas, United States, 77027
      • Performance pain and sports medicine
    • Kingwood, Texas, United States, 77339
      • Fondren Orthopedic Group, LLC
    • San Antonio, Texas, United States, 78240
      • Advanced Spine and Pain Center
    • Tyler, Texas, United States, 75701
      • Precision Spine Care
  • Utah
    • Saint George, Utah, United States, 84790
      • Southwest Spine and Pain
  • West Virginia
    • Charleston, West Virginia, United States, 25301
      • The Spine and Nerve Center of Saint Francis Hospital
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53221
      • Advanced Pain Management

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate degenerative lumbar spinal stenosis

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• not contraindicated as described in the labeled indications for use

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Superion® Indirect Decompression System (IDS); Superion® Indirect Decompression System (IDS) - Interspinous Spacer	Device: Superion® Indirect Decompression System (IDS); Superion® Indirect Decompression System (IDS) (Superion® implant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vertiflex® Patient Satisfaction Survey	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%.	3 Week Follow-Up Visit
Vertiflex® Patient Satisfaction Survey	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%.	6 Month Follow-Up Visit
Vertiflex® Patient Satisfaction Survey	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%.	12 Month Follow-Up Visit

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Study Director: Natalie Bloom Lyons, Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2016
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: June 5, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: LSS
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis
• Other Study ID Numbers: 16-VISS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No