Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
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.
Inclusion Criteria:

 -  Spinal stenosis

 -  Spondylolisthesis Degenerative disc disease (defined as back pain of discogenic origin
 with degeneration of the disc confirmed by history and radiographic studies)

 -  Fracture (including dislocation or subluxation)

 -  Spine tumor

 -  Scoliosis

 -  Lordotic deformities of the spine

 Exclusion Criteria:

 -  An active systemic or local infection

 -  Previous fusion attempt at index level

 -  A local inflammation with or without fever or leukocytosis

 -  Pregnancy

 -  Obesity (BMI >40 kg/m2)

 -  Drug or alcohol abuse

 -  Uncooperativeness or neurological or mental illness rendering the individual unwilling
 or unable to follow instructions

 -  Inability to restrict high activity level

 -  A suspected or documented metal allergy or intolerance

 -  A poor prognosis for good wound healing (e.g., decubitus ulcer, end-stage diabetes,
 severe protein deficiency and/or malnutrition)

 -  Any medical or surgical condition that would preclude the potential benefit of spinal
 implant surgery, prevent secure component fixation, or seriously increase the risk of
 tolerating any surgical procedure,

 -  Any other "contraindications" as enumerated in the device's "Instructions for Use".