For more information
on each clinical trial, and criteria
for who may participate, contact a health
care professional at the nearest Research
Organization listed here.
Applied Spine Technologies
Dynamic Stabilization for Lumbar Spinal
Stenosis With Stabilimax NZ® Dynamic Spine
Stabilization System
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 or two
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.
www.legandbackpainstudy.com
AxioMed Spine Corporation
Freedom Lumbar Disc in the Treatment
of Lumbar Degenerative Disc Disease (FLD)
This study will look at the result of
using the FLD device as an artificial lumbar
disc. The study will compare the safety
and effectiveness of the FLD artificial
lumbar disc to an already approved artificial
lumbar disc http://www.axiomed.com/
Degenerative Disc Disease (DDD)
Vertiflex, Incorporated
Investigating Superion™ In Spinal
Stenosis [ISISS]
The proposed prospective,
multi-center, randomized clinical trial
is designed to evaluate the safety and effectiveness
of the Superion™ ISS compared to the X-STOP®
IPD® device in healthy adults suffering
from at least 6 months of moderate spinal
stenosis symptoms who have been unresponsive
to conservative care.