Disk Herniated Lumbar Clinical Trial
Official title:
Efficacy and Safety of the Inter-laminar Device IntraSPINE® Associated With Discectomy in the Treatment of Lumbar Disc Herniation. A Single-blind, Randomised, Comparative, Multicentre Clinical Trial vs. Discectomy Alone.
IntraSPINE® is a novel device that, unlike interspinous positioned implants, is unique in
being placed more anteriorly in an interlaminar position, closer to the normal center of
rotation of the motion segment. Mechanical advantages are thus conferred over more
posteriorly positioned devices through the possibility of more physiological 'rocking' type
movements in flexion and extension . This enables IntraSPINE® to off-load the facet joints in
extension without blocking movement. Having a more anteriorly placed fulcrum also helps
control excessive flexion movements by virtue of an improved lever arm in conjunction with an
intact posterior tension band.
The underlying hypothesis of this work is that a clinical gain is achieved by adding an
IntraSPINE® interlaminar device to discectomy in patients suffering from a lumbar disc
herniation. This should result in an improvement in incapacity level and a reduction in pain.
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