Postmarket Registry for Evaluation of the Superion® Spacer

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).

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Key information

Conditions

Lumbar Spinal Stenosis Bone Diseases Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

(ACT) Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superion® Indirect Decompression System (IDS)

Device

Superion® Indirect Decompression System (IDS) (Superion® implant)

Primary outcomes

Vertiflex® Patient Satisfaction Survey

Time frame: 3 Week 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%.
Vertiflex® Patient Satisfaction Survey

Time frame: 6 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%.
Vertiflex® Patient Satisfaction Survey

Time frame: 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%.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Acronym: PRESS

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Sep 12, 2019
Registry last updated: Jul 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed