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A Study of the In-Space Device for Treatment of Moderate Spinal Stenosis

NCT00697827 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2012-06-11

Study results available
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Summary

The purpose of this study is to evaluate the safety and effectiveness of the In-Space compared to the X STOP Interspinous Process Distraction (IPD) device ("X STOP") for the treatment of patients experiencing intermittent neurogenic claudication secondary to moderate degenerative lumbar stenosis at one or two lumbar levels.

Conditions

  • Spinal Stenosis

Interventions

DEVICE

Interspinous Spacer device

Device: In-Space

DEVICE

Interspinous Process Distraction Device

Device: X STOP

Sponsors & Collaborators

  • Synthes USA HQ, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-06-30
Completion
2011-06-30

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 NCT00697827 on ClinicalTrials.gov