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Terminated Not applicable Interventional

Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System

ClinicalTrials.gov ID: NCT00529997

Public ClinicalTrials.gov record NCT00529997. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 9:27 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Clinical Study Comparing Dynamic Stabilization of the Lumbar Spine With the Stabilimax NZ® Dynamic Spine Stabilization System to Posterolateral Instrumented Fusion - In Patients With Lumbar Spinal Stenosis

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal stenosis at one contiguous vertebral levels from L1-S1. Safety and effectiveness will be assessed by means of primary study endpoints which address improvements in pain and function in the absence of major device related complications. The study hypothesis criteria for demonstrating safety and efficacy requires scientific evidence that patients classified as satisfying the primary study endpoint post device implantation is at least as good for Stabilimax NZ® recipients as that for patients undergoing fusion with posterior pedicle screw instrumentation at the 24 month followup assessment.

Study identification

NCT ID
NCT00529997
Recruitment status
Terminated
Study type
Interventional
Phase
Not applicable
Lead sponsor
Applied Spine Technologies
Industry
Enrollment
480 participants

Conditions and interventions

Eligibility (public fields only)

Age range
21 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2007
Primary completion
Nov 30, 2010
Completion
Nov 30, 2010
Last update posted
Aug 10, 2010

2007 – 2010

United States locations

U.S. sites
19
U.S. states
15
U.S. cities
19
Facility City State ZIP Site status
Surgical Specialty Hospital Phoenix Arizona 85015
Cedars Sinai Medical Center Hospital Los Angeles California 90048
Tri-City Medical Center Oceanside California 92056
Littleton Adventist Hospital Littleton Colorado 80122
New Britain General Hospital New Britain Connecticut 06052
Morton Plant Mease Clearwater Florida 33756
Largo Medical Center Largo Florida 33770
University Community Hospital at Carrolwood Tampa Florida 33614
Rush University Medical Center Chicago Illinois 60612
Upstate Medical Center Syracuse New York 13210
North Carolina Specialty Hospital Durham North Carolina 27704
Blanchard Valley Hospital Findlay Ohio 45840
Sacred Heart Medical Center Eugene Oregon 97401
Lehigh Valley Hospital Allentown Pennsylvania 18105
Wellmont Bristol Regional Medical Center Bristol Tennessee 37620
Vanderbilt University Medical Center Nashville Tennessee 37232
Presbyterian Plano Center for Diagnostics & Surgery Plano Texas 75093
University of Utah Hospital Salt Lake City Utah 84132
DePaul Medical Center Norfolk Virginia 23505

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00529997, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 10, 2010 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00529997 live on ClinicalTrials.gov.

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