MedTrace Logo

Assessing Superion Clinical Endpoints vs. Decompression

NCT03048955 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-06-12

No results posted yet for this study

Summary

PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct decompression at 60 months follow-up. Secondarily, the trial is intended to establish that Composite Clinical Success of the study group receiving the Superion® IDS at 24 months is not inferior to the success rate observed at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly, the trial is intended to establish that Composite Clinical Success of the population receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate observed at 24 months in patients treated with direct decompression.

Conditions

  • Spinal Stenosis, Lumbar Region With Neurogenic Claudication

Interventions

DEVICE

Superion® IDS

Device is a non-fusion, spinal column load-sharing device used to stabilize the spine at the implanted leve

PROCEDURE

Direct decompression Surgery

A surgical procedure - the control

Sponsors & Collaborators

  • VertiFlex, Incorporated

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-08
Primary Completion
2022-07-31
Completion
2025-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03048955 on ClinicalTrials.gov