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

Not Applicable

Terminated

Conditions: Degenerative Disc Disease
Spinal Stenosis
Spondylolisthesis

Interventions: Device: Trinica Anterior Lumbar Plate System

Registration Number: NCT00762723

Lead Sponsor: Zimmer Biomet

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 19

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".

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Trinica Anterior Lumbar Plate System	Trinica Anterior Lumbar Plate System with fixed screws only
Group 2	Trinica Anterior Lumbar Plate System	Trinica Anterior Lumbar Plate System with variable screws only
Group 3	Trinica Anterior Lumbar Plate System	Trinica Anterior Lumbar Plate with hybrid screw configuration (2 fixed-angle screws with 2 variable-angle screws).

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Loma Linda University Orthopedic Center
🇺🇸
San Bernardino, California, United States
Alabama Spine Institute
🇺🇸
Daphne, Alabama, United States
Ronderos Neurosurgery Center
🇺🇸
Mobile, Alabama, United States