Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Stopped early · Not applicable
Conditions studied: Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
In brief
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.
Key facts
- Study ID
- NCT00762723
- Run by
- Zimmer Biomet
- People needed
- 19
- Starts
- 2008-02-01
- Expected to finish
- 2012-09-01
- Last updated by the study team
- 2014-04-17
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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".
Where it is running
- Alabama Spine Institute — Daphne, Alabama, United States
- Ronderos Neurosurgery Center — Mobile, Alabama, United States
- Loma Linda University Orthopedic Center — San Bernardino, California, United States
Full record on ClinicalTrials.gov
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