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Clinical Trial Summary

The purpose of this European Union (EU) study to evaluate the safety and performance of the CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar intervertebral discs (L3 to S1) for patients requiring surgical intervention for total lumbar disc replacement for the treatment of debilitating, chronic low back pain.


Clinical Trial Description

Study Design: International, multicenter, open, clinical investigation with comparison to pre-operative

Currently there are two surgical procedures for the treatment of chronic low back pain: Spinal fusion and Total Disc Replacement. CAdiscâ„¢-L(Compliant Artificial disc - Lumbar) is a Lumbar total disc replacement product that preserves motion and restores disc height and stability

Surgical access is via a routine anterior approach with discectomy (removal of the diseased disc), which is performed prior to implantation of the CAdiscâ„¢-L. Instruments are then used to prepare the disc space and to controllably place the replacement disc at the target point. It is not intended for the surgery to differ in type, duration or risk to any other device of this nature. ;


Study Design

Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00949936
Study type Interventional
Source Ranier Technology Limited
Contact
Status Completed
Phase N/A
Start date October 2009
Completion date June 2010

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