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Study Evaluating the Safety and Effectiveness of the FLEXUS(TM) Interspinous Spacer

NCT01156675 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2018-06-01

Study results available
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Summary

The purpose of this investigation is to evaluate the safety and effectiveness of the FLEXUS™ Interspinous Spacer as compared to the XSTOP® Spacer for the treatment of patients who are suffering from lumbar spinal stenosis at one or two contiguous levels.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DEVICE

FLEXUS(TM) Interspinous Spacer

Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer

DEVICE

XSTOP® Interspinous Spacer

Treatment of lumbar spinal stenosis with the XSTOP® Spacer

Sponsors & Collaborators

  • Globus Medical Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

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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 NCT01156675 on ClinicalTrials.gov