Chronic Low Back Pain Clinical Trial
Official title:
Debilitating Low Back paIn: Multi-centre Safety and performanCe invEstigation Of CAdiscTM-L, Total Disc ReplacemeNt Therapy
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.
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. CAdisc™-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 CAdisc™-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.
;
Primary Purpose: Treatment
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