Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking (DISCERN)

This study has been completed.
Sponsor:
Information provided by:
Ranier Technology Limited
ClinicalTrials.gov Identifier:
NCT00949936
First received: July 30, 2009
Last updated: October 14, 2010
Last verified: October 2010
  Purpose

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.


Condition Intervention
Chronic Low Back Pain
Lumbar Degenerative Disc Disease
Device: CAdisc™-L (Total Disc Replacement)

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Debilitating Low Back paIn: Multi-centre Safety and performanCe invEstigation Of CAdiscTM-L, Total Disc ReplacemeNt Therapy

Resource links provided by NLM:


Further study details as provided by Ranier Technology Limited:

Primary Outcome Measures:
  • 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
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 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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00949936

Locations
Belgium
Antwerp, Belgium
Germany
Bogen, Germany
Netherlands
Zwolle, Netherlands
United Kingdom
Aberdeen, United Kingdom
Sponsors and Collaborators
Ranier Technology Limited
  More Information

No publications provided

Responsible Party: Ian Quirk : Worldwide Clinical & Regulatory Affairs Director, Ranier Technology Ltd
ClinicalTrials.gov Identifier: NCT00949936     History of Changes
Other Study ID Numbers: Ranier01/2008
Study First Received: July 30, 2009
Last Updated: October 14, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Ranier Technology Limited:
Spine surgery

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Intervertebral Disc Degeneration
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014