N/A
N=1,674
Postmarket Registry for Evaluation of the Superion® Spacer
Lumbar Spinal Stenosis
Bottom Line
View on ClinicalTrials.gov: NCT04087811 ↗Enrolled (actual)
1,674
Serious AEs
0.3%
Results posted
Apr 2023
Primary outcome: Primary: Vertiflex® Patient Satisfaction Survey — 1147 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Superion® Indirect Decompression System (IDS) (Device)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vertiflex® Patient Satisfaction Survey |
630 | — |
| PRIMARY Vertiflex® Patient Satisfaction Survey |
630 | — |
| PRIMARY Vertiflex® Patient Satisfaction Survey |
630 | — |
Summary
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04087811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.