Postmarket Registry for Evaluation of the Superion® Spacer

Lumbar Spinal Stenosis Clinical Trial

— PRESS  

Official title:

Postmarket Registry for Evaluation of the Superion® Spacer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087811
• Other study ID #: 16-VISS-01
• Status: Completed
• Start date: November 28, 2016
• Est. completion date: March 1, 2021

Study information

• Verified date: June 2022
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 1674
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Device:
• Superion® Indirect Decompression System (IDS)
Superion® Indirect Decompression System (IDS) (Superion® implant)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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