Clinical trial NCT04087811: Postmarket Registry for Evaluation of the Superion® Spacer
Official title: Postmarket Registry for Evaluation of the Superion® Spacer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis
Keywords: LSS
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2019-09-12
Enrollment: 1674
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vertiflex® Patient Satisfaction Survey
timeFrame: 3 Week Follow-Up Visit
measure: Vertiflex® Patient Satisfaction Survey
timeFrame: 6 Month Follow-Up Visit
measure: Vertiflex® Patient Satisfaction Survey
timeFrame: 12 Month Follow-Up Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: (ACT) Alabama Clinical Therapeutics, LLC
state: Alabama
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Scottsdale
country: United States
facility: HOPE Research Institute
state: Arizona
city: Buena Park
country: United States
facility: NuVation Pain Group
state: California
city: Burbank
country: United States
facility: Comprehensive Pain Physicians
state: California
city: Carlsbad
country: United States
facility: Coastal Pain and Spinal Diagnostics
state: California
city: Fountain Valley
country: United States
facility: Pain Medicine Associates
state: California
city: Fresno
country: United States
facility: Valley Pain Management
state: California
city: La Mesa
country: United States
facility: Pain Consultants of San Diego
state: California
city: Larkspur
country: United States
facility: California Orthopedics & Spine
state: California
city: Marina Del Rey
country: United States
facility: Remedy Pain Solutions, Inc.
state: California
city: Newport Beach
country: United States
facility: Newport Beach Headache & Pain
state: California
city: Poway
country: United States
facility: Pain Consultants of San Diego- Poway
state: California
city: San Diego
country: United States
facility: Relieve Pain Center
state: California
city: San Diego
country: United States
facility: Paul Kim MD Pain Management
state: California
city: San Diego
country: United States
facility: San Diego Comprehensive Pain Management Center
state: California
city: Santa Monica
country: United States
facility: Source Healthcare
state: California
city: Santa Rosa
country: United States
facility: Evolve Restorative Center
state: California
city: Temecula
country: United States
facility: Innovative Pain Treatment Solutions
state: California
city: Walnut Creek
country: United States
facility: Intergrated Pain Management Medical Group, Inc.
state: California
city: Fort Collins
country: United States
facility: Front Range Pain Medicine
state: Colorado
city: Trumbull
country: United States
facility: The Orthopaedic & Sports Medicine Center
state: Connecticut
city: Washington
country: United States
facility: International Spine Pain & Performance Center
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Southeast Spine Associates
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Interventional Spine and Pain Medicine
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Spine Center
state: Florida
city: Jupiter
country: United States
facility: Jupiter Interventional Pain Management
state: Florida
city: Merritt Island
country: United States
facility: Florida Pain Institute
state: Florida
city: Orlando
country: United States
facility: Lake Nona Medical Arts
state: Florida
city: Port Charlotte
country: United States
facility: Southwest Florida Pain Center
state: Florida
city: Sebastian
country: United States
facility: Florida Pain Management Associates
state: Florida
city: Tampa
country: United States
facility: Tampa Pain Relief Center, Inc.
state: Florida
city: Brunswick
country: United States
facility: The Spine Center of Southeast Georgia
state: Georgia
city: Newnan
country: United States
facility: Georgia Pain and Spine Care
state: Georgia
city: Coeur d'Alene
country: United States
facility: AXIS Spine Center
state: Idaho
city: Bolingbrook
country: United States
facility: AMITA Health Bolingbrook Pain Management Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center Department of Anesthesiology
state: Illinois
city: Kansas City
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Neuroscience Research Center, LLC
state: Kansas
city: Paducah
country: United States
facility: Pain Management Center of Paducah, KY
state: Kentucky
city: Cambridge
country: United States
facility: Pain and Wellness
state: Massachusetts
city: Columbia
country: United States
facility: Columbia Interventional Pain Center
state: Missouri
city: Lee's Summit
country: United States
facility: Pain Management Associates
state: Missouri
city: Henderson
country: United States
facility: Comprehensive and Interventional Pain Management
state: Nevada
city: Reno
country: United States
facility: Advanced Pain Specialists
state: Nevada
city: Brick
country: United States
facility: Center for Pain Control at Jasper Ambulatory Surgical Center
state: New Jersey
city: East Windsor
country: United States
facility: Spine Institute of North America, LLC
state: New Jersey
city: Shrewsbury
country: United States
facility: Premier Pain Center
state: New Jersey
city: Somerset
country: United States
facility: University Clinical Research Center
state: New Jersey
city: Whiting
country: United States
facility: Pain Management at Garden State Medical Center
state: New Jersey
city: East Syracuse
country: United States
facility: Upstate Orthopedics
state: New York
city: New York
country: United States
facility: Ainsworth Institute of Pain Management
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Comprehensive Pain Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Outpatient Center
state: Ohio
city: Edmond
country: United States
facility: Summit Medical Center
state: Oklahoma
city: East Norriton
country: United States
facility: Performance Spine & Sports Physicians, PC
state: Pennsylvania
city: Exton
country: United States
facility: Center for Interventional Pain & Spine
state: Pennsylvania
city: Murrells Inlet
country: United States
facility: SC Pain and Spine
state: South Carolina
city: Conroe
country: United States
facility: North Lake Pain Consultants
state: Texas
city: Houston
country: United States
facility: Performance Pain and Sports Medicine
state: Texas
city: Kingwood
country: United States
facility: Fondren Orthopedic Group, LLC
state: Texas
city: San Antonio
country: United States
facility: Advanced Spine and Pain Center
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Saint George
country: United States
facility: Southwest Spine and Pain
state: Utah
city: Charleston
country: United States
facility: The Spine and Nerve Center of Saint Francis Hospital
state: West Virginia
city: Greenfield
country: United States
facility: Advanced Pain Management
state: Wisconsin
Study officials:
affiliation: Boston Scientific Corporation
name: Natalie Bloom Lyons
role: STUDY_DIRECTOR
References: