Premia Spine launched its FDA-approved U.S. pivotal Investigational Device Exemption study of the TOPS™ posterior arthroplasty device vs. traditional lumbar fusion in the treatment of degenerative grade I spondylolisthesis and spinal stenosis.
The randomized study will enroll 330 patients at 30 clinical sites, measuring ODI, VAS, neurologic function, device integrity, reoperation rates and other quantitative outcomes. The study seeks to establish superiority of TOPS vs. fusion.
Premia Spine launched its FDA-approved U.S. pivotal Investigational Device Exemption study of the TOPS™ posterior arthroplasty device vs. traditional lumbar fusion in the treatment of degenerative grade I spondylolisthesis and spinal stenosis.
The randomized study will enroll 330 patients at 30 clinical sites, measuring ODI, VAS,...
Premia Spine launched its FDA-approved U.S. pivotal Investigational Device Exemption study of the TOPS™ posterior arthroplasty device vs. traditional lumbar fusion in the treatment of degenerative grade I spondylolisthesis and spinal stenosis.
The randomized study will enroll 330 patients at 30 clinical sites, measuring ODI, VAS, neurologic function, device integrity, reoperation rates and other quantitative outcomes. The study seeks to establish superiority of TOPS vs. fusion.
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