Postmarket Registry for Evaluation of the Superion® Spacer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Postmarket Registry for Evaluation of the Superion® Spacer

Conditions
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Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: Superion® Indirect Decompression System (IDS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Superion® Indirect Decompression System (IDS)<br>Superion® Indirect Decompression System (IDS) - Interspinous Spacer | Device: Superion® Indirect Decompression System (IDS)<br>* Superion® Indirect Decompression System (IDS) (Superion® implant)<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LSS