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

Primary Purpose

Chronic Low Back Pain, Lumbar Degenerative Disc Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
CAdisc™-L (Total Disc Replacement)
Sponsored by
Ranier Technology Limited
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Spine surgery

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Improvement of 15 points on the Oswestry Disability Index (ODI) scale at 3 months post-surgery, compared to baseline

Secondary Outcome Measures

Full Information

First Posted
July 30, 2009
Last Updated
October 14, 2010
Sponsor
Ranier Technology Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00949936
Brief Title
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
Acronym
DISCERN
Official Title
Debilitating Low Back paIn: Multi-centre Safety and performanCe invEstigation Of CAdiscTM-L, Total Disc ReplacemeNt Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ranier Technology Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 discs (L3 to S1) for patients requiring surgical intervention for total lumbar disc replacement for the treatment of debilitating, chronic low back pain.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain, Lumbar Degenerative Disc Disease
Keywords
Spine surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
CAdisc™-L (Total Disc Replacement)
Primary Outcome Measure Information:
Title
Improvement of 15 points on the Oswestry Disability Index (ODI) scale at 3 months post-surgery, compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Antwerp
Country
Belgium
City
Bogen
Country
Germany
City
Zwolle
Country
Netherlands
City
Aberdeen
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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