Degeneration of Lumbar Intervertebral Disc Clinical Trial
Official title:
A Multi-Center Prospective Randomized Study Comparing Supplemental Posterior Instrumentation, Aspen™ Spinous Process System Versus Pedicle Screw Fixation, in Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
The purpose of this clinical investigation is to evaluate the Aspen™ device compared to pedicle screw instrumentation for posterior fixation in the treatment of patients with degenerative disc disease and/or spondylolisthesis. The Aspen™ device will be compared to pedicle screw instrumentation in Oswestry Disability Index (ODI) improvement and success of fusion.
This is a multi-center, prospective randomized clinical study to evaluate the clinical
outcome of subjects with degenerative disc disease (DDD) (defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and radiographic studies) and/or
spondylolisthesis utilizing either Aspen Spinous Process Fixation System or Pedicle Screws
for supplemental posterior instrumentation as an adjunct to an anterior or lateral approach
to lumbar interbody fusion.
The primary hypothesis is that change in Oswestry Disability Index (ODI) of subjects in the
study group (Aspen) will be non-inferior to the control group (pedicle screw
instrumentation). The non-inferiority margin is pre-specified to be 10 ODI score points. If
the non-inferiority is established, superiority of Aspen to the control will be tested.
The study will involve up to 25 investigational sites. Enrollment is expected to take
approximately 24 months. Subjects will be followed for 2 years, with the anticipated duration
of the study being approximately 4 years from start to finish.
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