Degenerative Disc Disease Clinical Trial
Official title:
A Comparison of Clinical Outcomes Comparing Fixed-angle, Variable-angle, and Hybrid Screw Configuration for the Trinica(R) Anterior Lumbar Plate System
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability. The system provides the surgeon with the ability to supplement an interbody device with anterior plate fixation. The device's bone-plate interface is enhanced through use of fixed-angled screws,variable-angle screws or a combination of both to accommodate various combinations of screw configurations, resulting in enhanced fixation tailored to individual patient needs. Clinical outcomes data, including a comparison of different screw configurations, is needed to support the use and of the Trinica ALP System.
In the cervical spine, literature shows that a static plate utilizing fixed screws loses its
ability to load share and to limit motion following subsidence of the interbody spacer. In
contrast, a dynamic plate system utilizing variable-angle screws maintains load-sharing and
stiffness following subsidences. Increasing the load on the bone graft in the interbody
space increases the rate of graft fusion. Although literature exists supporting the in vivo
use of anterior cervical plate systems and the advantages of screw angulation, there is no
data evaluating and supporting the use of anterior plate systems in the lumbar spine. The
different biomechanical loads between cervical and lumbar spine suggest cervical data may
not generalize to the lumbar spine. Additionally, it will be useful to characterize the
effect of different screw configurations on subsidence and stress shielding and fusion
success. The proposed study will not only assess clinical outcomes following Trinica ALP
implantation, but will also provide valuable comparison data regarding two different screw
configurations.
The study is a prospective, randomized, between groups design. The subject pool will be
comprised of individuals who are appropriate for spinal fusion surgery, and who meet the
inclusion criteria. Subjects will be randomly assigned to one of three screw configurations.
All subjects will receive structural allograft (Puros A Anterior Allograft) as interbody
support. Other procedures identified by the surgeon to be in the best interest of the
patient may be completed but are not required by the protocol.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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