Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01549366|
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : March 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Degeneration of Lumbar Intervertebral Disc||Device: Aspen Spinous Process Fixation Device Device: Pedicle Screws||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Aspen Spinous Process Fixation Device
Subjects randomized to the Aspen study arm will have the Aspen device implanted as supplemental posterior fixation only and according to the manufacturer's recommendations.
Device: Aspen Spinous Process Fixation Device
The Aspen device will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
Active Comparator: Pedicle Screws
Subjects randomized to the pedicle screw group will have polyaxial top loading pedicle screws implanted according to the standard procedures and practices at that institution. The procedure may be performed according to surgeon preference, including a traditional open, minimally invasive or percutaneous approach. Only pedicle screws cleared by FDA for this indication will be used in this study.
Device: Pedicle Screws
Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549366
|United States, Kentucky|
|Paducah, Kentucky, United States, 42001|
|United States, New York|
|Buffalo Spine Surgery|
|Lockport, New York, United States, 14094|
|United States, Oregon|
|Medford, Oregon, United States, 97504|
|Principal Investigator:||Patel||University of Colorado, Denver|
|Principal Investigator:||Cappuccino||Buffalo Spine Surgery|