Postmarket Registry for Evaluation of the Superion® Spacer

Completed

• 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.

Study Timeline

• Study Start: 2016-11-28
• Study First Submitted: 2019-06-05
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Results First Submitted: 2022-02-28
• Status Verified: 2022-06
• Results First Submitted QC: 2023-04-03
• Results First Posted: 2023-04-04
• Last Update Submitted: 2023-07-03
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1674

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 & 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%.

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)