Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
Conditions
Keywords
Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, ALIF, fusion success, Anterior Lumbar Plate, fixed versus variable screw configurations, Anterior Lumbar Interbody Fusion to treat spinal instability
Brief summary
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.
Detailed description
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.
Interventions
DEVICETrinica Anterior Lumbar Plate System
Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment) | Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months | \- Fusion Assessment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Trinica Anterior Lumbar Plate System with fixed screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration. | 5 |
| Group 2 Trinica Anterior Lumbar Plate System with variable screws only
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration. | 11 |
| Group 3 Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).
Trinica Anterior Lumbar Plate System: Trinica Anterior Lumbar Plate System accommodates the use of either fixed- or variable-angle screws. This study is a comparison of clinical outcomes from anterior lumbar interbody fusion patients receiving the Trinica Anterior Lumbar Plate system with either all fixed-angle screws, variable-angle screws, or a hybrid configuration. | 3 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study Terminated slow enrollement | 5 | 5 | 3 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 54 Years | 51 Years | 45 Years | 51 Years |
| Sex: Female, Male Female | 1 Participants | 6 Participants | 1 Participants | 8 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 2 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 5 | 4 / 11 | 0 / 3 |
| serious Total, serious adverse events | 1 / 5 | 0 / 11 | 0 / 3 |
Outcome results
Primary
Clinical Outcomes (Oswestry Disability Index, SF-12, Numeric Pain Rating Scale, Surgeon Assessment, Patient Self Assessment, Radiological Assessment)
\- Fusion Assessment
Time frame: Pre-operative, Operative; Follow-ups at 3 Months, 6 Months, 12 Months, and 24 Months
Population: Data not analyzed because study was stopped due to slow enrollment.