Chronic Low Back PainDISCERNNCT00949936
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
A study testing CAdisc™-L (Total Disc Replacement) in people with Chronic Low Back Pain and Lumbar Degenerative Disc Disease, run by Ranier Technology Limited at 4 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Chronic Low Back Pain, Lumbar Degenerative Disc Disease
- What is being tested?
- CAdisc™-L (Total Disc Replacement)
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 4 sitesin 4 countries
- Study dates
- Oct 2009to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Debilitating Low Back paIn: Multi-centre Safety and performanCe invEstigation Of CAdiscTM-L, Total Disc ReplacemeNt Therapy
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.
Read the 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.
- Being tested
- CAdisc™-L (Total Disc Replacement)
- Keywords
- Spine surgery
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAdisc™-L (Total Disc Replacement)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of 15 points on the Oswestry Disability Index (ODI) scale at 3 months post-surgery, compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2009 (estimated)
- Study startOct 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Ranier Technology Limited
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949936
- Sponsor's protocol ID
- Ranier01/2008
- Acronym
- DISCERN
- Status last verified
- Oct 2010
- First submitted
- 30 Jul 2009
- Last updated
- 15 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Debilitating Low Back paIn: Multi-centre Safety and performanCe invEstigation Of CAdiscTM-L, Total Disc ReplacemeNt Therapy
- ClinicalTrials.gov ID
- NCT00949936
- Acronym / sponsor ID
- DISCERN / Ranier01/2008
- Keywords
- Spine surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ranier Technology LimitedIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Study completion
- Jun 2010 (actual)
- First posted
- 31 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAdisc™-L (Total Disc Replacement) | Device | – |
Primary outcome
Improvement of 15 points on the Oswestry Disability Index (ODI) scale at 3 months post-surgery, compared to baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAdisc™-L (Total Disc Replacement) in people with Chronic Low Back Pain and Lumbar Degenerative Disc Disease, run by Ranier Technology Limited at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Germany, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of 15 points on the Oswestry Disability Index (ODI) scale at 3 months post-surgery, compared to baseline. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2010.