Lumbar Spinal Stenosis Clinical Trial
Official title:
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
NCT number | NCT04192591 |
Other study ID # | A4082 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | January 30, 2020 |
Est. completion date | May 2032 |
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Status | Recruiting |
Enrollment | 214 |
Est. completion date | May 2032 |
Est. primary completion date | June 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Alliance Spine and Pain Centers | Atlanta | Georgia |
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | Coastal Research Institute, LLC | Carlsbad | California |
United States | The Spine and Nerve Center of Saint Francis Hospital | Charleston | West Virginia |
United States | Rush University Medical Center | Chicago | Illinois |
United States | Ascension Alexian Brothers | Elk Grove Village | Illinois |
United States | Pacific Sports and Spine, LLC | Eugene | Oregon |
United States | Holy Cross Hospital | Fort Lauderdale | Florida |
United States | The Orthopaedic Institute | Gainesville | Florida |
United States | University of Kansas Hospital | Kansas City | Kansas |
United States | Central Texas Pain Institute | Killeen | Texas |
United States | Center for Interventional Pain and Spine | Lancaster | Pennsylvania |
United States | SC Pain and Spine Specialists | Murrells Inlet | South Carolina |
United States | Weill Cornell Medical University | New York | New York |
United States | Neuroscience Research Center, LLC | Overland Park | Kansas |
United States | North Idaho Day Surgery | Post Falls | Idaho |
United States | Vitamed Research | Rancho Mirage | California |
United States | Pacific Research Institute | Santa Rosa | California |
United States | Swedish Health Services | Seattle | Washington |
United States | Florida Pain Management | Sebastian | Florida |
United States | Northwest Pain Care | Spokane | Washington |
United States | Spinal Diagnostics | Tualatin | Oregon |
United States | Precision Spine Care | Tyler | Texas |
United States | IPM Medical Group Inc. | Walnut Creek | California |
United States | Centurion Spine and Pain | Waycross | Georgia |
United States | Forest Health Medical Center | Ypsilanti | Michigan |
Lead Sponsor | Collaborator |
---|---|
Boston Scientific Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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