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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
The Aspen device will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
Clint Hill
Paducah, Kentucky, United States
Buffalo Spine Surgery
Lockport, New York, United States
Andy Kranenburg
Medford, Oregon, United States
Absolute change in Oswestry Disability Index (ODI)
Time frame: baseline to 12 months post-operative
Fusion success
Time frame: 12 months and 24 months
Neurological status
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in EQ-5D-3L
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in SF-36
Time frame: Baseline, 12 months & 24 months
Change in Visual Analogue Scale (VAS) (pain)
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Change in Zurich Claudication Questionnaire
Time frame: Baseline, 12 months & 24 months
Pain medication usage
Time frame: Baseline, surgery, 6 weeks, 3 months, 6 months, 12 months, & 24 months
Operative parameters (estimate blood loss, fluor time, length of hospital stay)
Time frame: Intraoperative
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