Status:
TERMINATED
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Lead Sponsor:
Zimmer Biomet
Conditions:
Degenerative Disc Disease
Spinal Stenosis
Eligibility:
All Genders
Phase:
NA
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 w...
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 dyna...
Eligibility Criteria
Inclusion
- 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
- 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".
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00762723
Start Date
February 1 2008
End Date
September 1 2012
Last Update
April 17 2014
Active Locations (3)
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1
Alabama Spine Institute
Daphne, Alabama, United States, 36526
2
Ronderos Neurosurgery Center
Mobile, Alabama, United States, 36608
3
Loma Linda University Orthopedic Center
San Bernardino, California, United States, 92408