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Efficacy and Safety of IntraSPINE® Associated With Discectomy in the Treatment of Lumbar Disc Herniation. — INTREUR  

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.

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03752671
Study type Interventional
Source Quanta Medical
Contact Pierre Guigui, Professor
Phone 00 33 1 47 08 63 41
Email b.hill@quanta-medical.com
Status Recruiting
Phase N/A
Start date June 20, 2019
Completion date June 20, 2023
View Details
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