Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking (DISCERN)
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.
Chronic Low Back Pain
Lumbar Degenerative Disc Disease
Device: CAdisc™-L (Total Disc Replacement)
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Debilitating Low Back paIn: Multi-centre Safety and performanCe invEstigation Of CAdiscTM-L, Total Disc ReplacemeNt Therapy|
- Improvement of 15 points on the Oswestry Disability Index (ODI) scale at 3 months post-surgery, compared to baseline
|Study Start Date:||October 2009|
|Study Completion Date:||June 2010|
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.