MedTrace Logo

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

NCT00529997 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2010-08-11

No results posted yet for this study

Summary

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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DEVICE

Stabilimax NZ® Dynamic Spine Stabilization System

Surgical Implantation

Sponsors & Collaborators

  • Applied Spine Technologies

    lead INDUSTRY

Principal Investigators

  • Richard Guyer, MD · Texas Back Institute

  • David Musante, M.D. · Triangle Orthopedics Associates

  • Neel Anand, M.D. · Cedars Sinai Medical Center Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT00529997 on ClinicalTrials.gov