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Effects of X-STOP® Versus Laminectomy Study

NCT00558129 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-12-08

No results posted yet for this study

Summary

To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DEVICE

X-STOP®

Surgical implantation of X-STOP IPD device

PROCEDURE

Laminectomy

Standard laminectomy techniques will be used and may include laminotomy, foraminotomy and/or laminectomy as appropriate. In some cases at the discretion of the treating physician, fusion may indicated to stabilize the segment.

Sponsors & Collaborators

  • Medtronic Spine LLC

    lead INDUSTRY

Principal Investigators

  • Volker Sonntag, MD · Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Completion
2011-11-30

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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 NCT00558129 on ClinicalTrials.gov