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

N/AActive Not RecruitingNCT04192591

Boston Scientific Corporation166 enrolled

Overview

To compile real-world outcomes of the Superion™ IDS in routine clinical practice.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

166

Conditions

Lumbar Spinal Stenosis

Interventions

Superion™ IDS deviceDEVICE

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.

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

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

Locations (23)

Coastal Research Institute, LLC

Carlsbad, California, United States

Outcomes

Primary Outcomes

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: 1. 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 2. No reoperations, removals, revisions, or supplemental fixation at the index level(s) 3. 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

Time frame: 24-Months

Secondary Outcomes

Patient Satisfaction: VertiFlex® Patient Satisfaction Survey

Proportion of subjects with VertiFlex® Patient Satisfaction Survey scoring ≥3 on a 4-point scale

Time frame: 24-, 36-, 48- and 60-Months

Data from ClinicalTrials.gov

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