A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Study Overview
=================
Brief Summary
-----------------
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

Detailed Description
-----------------
To compile real-world outcomes of the Superion™ IDS in routine clinical practice, when used according to the applicable Directions for Use

Official Title
-----------------
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)

Conditions
-----------------
Lumbar Spinal Stenosis

Intervention / Treatment
-----------------
* Device: Superion™ IDS device


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: 45 years of age or older when written informed consent is obtained Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart). Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral access), and the nerve root canal (foraminal). Subject signed a valid, IRB-approved informed consent form (ICF) provided in English. Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups. Able to independently read and complete all questionnaires and assessments provided in English Key Exclusion Criteria: Axial back pain only. Fixed motor deficit in lower extremity(ies) due to LSS. Has any pain-related diagnosis, medical/psychological condition or external factors that, in the investigator's medical judgment, might confound reporting of study outcomes (e.g. history of pelvic pain, anginal pain, chronic migraine, involved in litigation, workmen's compensation, spinal tumor) Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Superion™ IDS device<br>Superion™ Indirect Decompression System (IDS) | Device: Superion™ IDS device<br>* The Superion™ IDS is a minimally-invasive spinal implant that treats LSS symptoms by limiting extension at the symptomatic level that compresses the neural elements and is designed for percutaneous surgical placement.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of success at the 24-month follow-up visit | Non-inferiority of overall subject success at the 24-Month visit vs. the 24-month visit in IDE trial. An individual subject will be considered a success if they meet all of the following conditions at the 24-month follow-up visit: Clinically significant improvement of neurogenic claudication symptoms as determined by meeting at least two of three domains of the ZCQ ≥ 0.5-point improvement in physical function ≥ 0.5-point improvement in symptom severity ≤ 2.5 point on patient satisfaction domain No reoperations, removals, revisions, or supplemental fixation at the index level(s) No major implant or procedure-related complications no dislodgement, migration, or device deformation no new or persistent worsened neurological deficit at the index level† no unhealed spinous process fractures † Defined as a serious adverse event wherein there is any new/worsening of motor or sensory function at 12 months, compared to baseline, which persists to 24 months | 24-Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction: VertiFlex® Patient Satisfaction Survey | Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale | 24-, 36-, 48- and 60-Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lumbar Spinal Stenosis, LSS, Chronic Pain, Leg Pain