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This prospective, post-market, open label clinical study is designed to measure the posterolateral fusion rate at 24 months post operative in subjects who have undergone a posterolateral fusion using Trinity Elite with or without local bone.
The study is a prospective, post-market, open label clinical study. Up to 10 sites across the United States, with a total enrollment of approximately 120 subjects, will be enrolling subjects. The primary objective of this study is to measure the posterolateral fusion rate at 24 months when posterolateral arthrodesis is performed using Trinity Elite with or without local bone and with supplemental pedicle screw fixation. The primary endpoints are radiographic evidence of posterolateral fusion and the absence of serious adverse events attributable to Trinity ELITE. The secondary objectives of this study are to measure the clinical and economic outcomes when posterolateral arthrodesis is performed using Trinity Elite and/or local bone with supplemental pedicle screw fixation.
Observational Model: Cohort, Time Perspective: Prospective
Degenerative Disc Disease
Enrolling by invitation
Published on BioPortfolio: 2016-11-22T14:08:21-0500
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Nucleus pulposus (NP) cell senescence is an important cellular feature within the degenerative disc. It is known that a very acidic niche exists in the degenerative disc, which participates in regulat...
Degenerative changes in the INTERVERTEBRAL DISC due to aging or structural damage, especially to the vertebral end-plates.
The dissolving of the NUCLEUS PULPOSUS, the semi-gelatinous tissue of a displaced INTERVERTEBRAL DISC. It is usually achieved by the direct injection of a proteolytic enzyme, especially CHYMOPAPAIN, into the herniated disc.
Fibrocartilage inner core of the intervertebral disc. Prolapsed or bulged nucleus pulposus leads to INTERVERTEBRAL DISC DISPLACEMENT while proliferation of cells in the nucleus pulposus is associated with INTERVERTEBRAL DISC DEGENERATION.
An INTERVERTEBRAL DISC in which the NUCLEUS PULPOSUS has protruded through surrounding ANNULUS FIBROSUS. This occurs most frequently in the lower lumbar region.
The replacement of intervertebral discs in the spinal column with artificial devices. The procedure is done in the lumbar or cervical spine to relieve severe pain resulting from INTERVERTEBRAL DISC DEGENERATION.
Osteoporosis is a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in women following menopause and often leading to curvature of the spine from vertebral collapse. Follow and track&n...