Lumbar Degenerative Disc DiseaseNCT02139527
CARES Lumbar Artificial Disc Registry
An observational study of Lumbar Degenerative Disc Disease, run by DePuy Spine.
Trial summary
The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- Total Disc Replacement
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Aug 2009
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that undergo lumbar total disc replacement (TDR); this includes patients treated with either the CHARITE disc or the ProDisc-L disc
Who may be able to join
- Treated with the lumbar TDR.
- Signed IRB approved consent document.
Who cannot join
- None known.
About this study
Official title: The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol
The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.
Read the detailed description
The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.
- Conditions
- Lumbar Degenerative Disc Disease
- Being tested
- Total Disc Replacement
- Keywords
- arthroplasty, spinal, CHARITE, PRODISC-L, PRODISC, disc, replacement, lumbar
- 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.
Total Disc ReplacementDevice
Also called CHARITE™ Artificial Disc, PRODISC®-L Total Disc Replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oswestry Disability Index (ODI) Score
The ODI assesses several domains of function affected by low back pain. A change of 15 points from baseline is considered a clinical meaningful difference for the individual. The change from pre operative baseline to each follow-up assessment will be calculated.
Measured: 3, 6, 12, 24, 36, 48, and 60 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2014 (estimated)
- Study startMay 2007
- Primary completionAug 2009
- Study completionAug 2009
Why it stopped: Low enrollment and follow-up data on enrolled patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Disc DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- DePuy Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02139527
- Sponsor's protocol ID
- 06-CAD-01
- Status last verified
- May 2014
- First submitted
- 11 Feb 2014
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol
- ClinicalTrials.gov ID
- NCT02139527
- Acronym / sponsor ID
- 06-CAD-01
- Conditions
- Lumbar Degenerative Disc Disease
- Keywords
- arthroplasty, spinal, CHARITE, PRODISC-L, PRODISC, disc, replacement, lumbar
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment and follow-up data on enrolled patients.
- Enrolment
- 120 participants (actual)
- Lead sponsor
- DePuy SpineIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 May 2014 (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 the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.
Detailed description
The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that undergo lumbar total disc replacement (TDR); this includes patients treated with either the CHARITE disc or the ProDisc-L disc
Key inclusion criteria (2 listed)
- Treated with the lumbar TDR.
- Signed IRB approved consent document.
Key exclusion criteria (1 listed)
- None known.
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 |
|---|---|---|
| Total Disc ReplacementAlso: CHARITE™ Artificial Disc, PRODISC®-L Total Disc Replacement | Device | – |
Primary outcome
Change in Oswestry Disability Index (ODI) Score
Time frame: 3, 6, 12, 24, 36, 48, and 60 months post operative
The ODI assesses several domains of function affected by low back pain. A change of 15 points from baseline is considered a clinical meaningful difference for the individual. The change from pre operative baseline to each follow-up assessment will be calculated.
Results and safety
The study was stopped early (reason given: Low enrollment and follow-up data on enrolled patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Degenerative Disc Disease, run by DePuy Spine.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Low enrollment and follow-up data on enrolled patients.). Results are not available in the source record.
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?
Change in Oswestry Disability Index (ODI) Score (time frame: 3, 6, 12, 24, 36, 48, and 60 months post operative). 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 May 2014; AzTrials last refreshed its copy on 27 Oct 2026.