Status:
COMPLETED
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
Lead Sponsor:
Ranier Technology Limited
Conditions:
Chronic Low Back Pain
Lumbar Degenerative Disc Disease
Eligibility:
All Genders
25-65 years
Phase:
NA
Brief 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 di...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Male or non pregnant, non-lactating female
- 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
- Back or leg pain of unknown aetiology
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00949936
Start Date
October 1 2009
End Date
June 1 2010
Last Update
October 15 2010
Active Locations (4)
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1
Antwerp, Belgium
2
Bogen, Germany
3
Zwolle, Netherlands
4
Aberdeen, United Kingdom