N/A Completed N=1,674

Postmarket Registry for Evaluation of the Superion® Spacer

Lumbar Spinal Stenosis

Source: ClinicalTrials.gov NCT04087811 ↗

Enrolled (actual)

1,674

Serious AEs

0.3%

Results posted

Apr 2023

Primary outcomePrimary: Vertiflex® Patient Satisfaction Survey — 1147 Participants

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Vertiflex® Patient Satisfaction Survey	630	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.