Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
NCT ID: NCT00949936
Last Updated: 2010-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2009-10-31
2010-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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CAdisc™-L (Total Disc Replacement)
Eligibility Criteria
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Inclusion Criteria
* Aged between 25-65 years (inclusive)
* BMI \< 35
* Preoperative ODI \> 30 points
* Chronic low back pain, and is in the opinion of the investigator a suitable candidate for anterior lumbar surgery
* Completed at least 6 months of conservative treatment without obtaining adequate symptomatic relief
* Degenerative disc changes at a single level between L3 - L4, or L4 - L5, or L5 - S1 as confirmed by positive discography and visualized by X-Ray, CT or MRI scan and/or with one or more of the following:
* Decrease in disc height \< 50% (or up to 80% and no benefit from facet injections)
* Annular thickening
* Herniated nucleus pulpous
* Subject is able to give voluntary, written informed consent to participate in this investigation and from whom written consent must be obtained prior to enrolment.
Exclusion Criteria
* Radicular or sciatic pain which is more severe than low back pain
* Previous lumbar spinal surgery which could affect the trial outcome (e.g., disc replacement)
* Obvious signs of psychological or worker's compensation or litigation claim elements to their condition, or are actively engaged in such activities
* Subject is unwilling or unable to give consent or adhere to the follow-up programme
* Active infection or metastatic disease
* Non-degenerative spondylolisthesis
* Degenerative spondylolisthesis \> grade 1
* Known allergy to any of the implant materials
* Osteoporosis (if suspected to be confirmed by bone density being 2.5SD below normal as assessed using DEXA analysis in post-menopausal females if suggested by X-ray or other risk factors)
* Osteopenia
* Bony lumbar stenosis
* Pars defect
* Isolated radicular compression syndromes, especially due to disc herniation
* Clinically compromised vertebral bodies at the affected levels due to current or past trauma
* Subject is skeletally immature as determined by the investigator
* Subject has participated in another clinical investigation or study with an investigational medical device within the last 60 days
* Concomitant medications that are known significantly to interfere with bone/soft tissue healing, e.g. steroids.
* Uncorrected iliac, aorto-iliac, or aortic aneurysm disease.
* Spinal instability (\> 3mm translation or \> 5° angulation) confirmed by functional radiological assessment.
* Degenerative disc changes at the L6 - S1 level
25 Years
65 Years
ALL
No
Sponsors
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Ranier Technology Limited
INDUSTRY
Responsible Party
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Ranier Technology Ltd
Locations
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Antwerp, , Belgium
Bogen, , Germany
Zwolle, , Netherlands
Aberdeen, , United Kingdom
Countries
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Other Identifiers
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Ranier01/2008
Identifier Type: -
Identifier Source: org_study_id