Degenerative Disc DiseaseNCT00215332
CHARITE™ vs. ALIF 5-Year Follow-up
An observational study of Degenerative Disc Disease, run by DePuy Spine at 10 sites in United States.
Trial summary
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- CHARITE
- Type of treatment
- Medical device
- How many people
- 367 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2005to Jul 2007
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study,
- Still have the original implant they received in their index surgery.
Who cannot join
- None
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Charite Site 15
Boston, Massachusetts, 02120
Charite Site 11
Chicago, Illinois, 60640
Charite Site 07
Columbus, Ohio, 43214
Charite Site 06
Golden, Colorado, 80401
Charite Site 14
Lockport, New York, 14094
Charite Site 13
Los Angeles, California, 90048
Charite Site 03
Louisville, Kentucky, 40202
Charite Site 10
New York, New York, 10003
Charite Site 01
Plano, Texas, 75093
Charite Site 02
Towson, Maryland, 21204
About this study
Official title: Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
Read the detailed description
This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF.
This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.
- Conditions
- Degenerative Disc Disease
- Being tested
- CHARITE
- Keywords
- arthroplasty, lumbar, disc
- 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.
CHARITEDevice
Lumbar Total Disc Replacement
| Study group | Role | What they receive |
|---|---|---|
| Training- CHARITE | Non-Randomized Training (TDR with CHARITE) Receives: Device: CHARITE | |
| CHARITE | Randomized Subjects treated by Lumbar Total Disc Replacment with CHARITE Receives: Device: CHARITE | |
| Control | Randomized Subjects treated by ALIF with BAK cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Success
ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline.
Measured: 5 Years
Secondary outcomes (1)
Secondary Endpoints
Components of the Overall Success definition (neurological and ODI scores) Visual Analog Scale (VAS) Disc height Range of Motion Migration of the device Radiolucency
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Time perspective
- Prospective
- Enrolment
- 367 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DePuy Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel H Stoutenburgh, Study director, DePuy Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215332
- Sponsor's protocol ID
- P040006
- Status last verified
- Apr 2015
- First submitted
- 14 Sep 2005
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Five-year Follow-up of the CHARITÉ™ Artificial Disc Compared to Anterior Lumbar Interbody Fusion With the BAK Cage.
- ClinicalTrials.gov ID
- NCT00215332
- Acronym / sponsor ID
- P040006
- Conditions
- Degenerative Disc Disease
- Keywords
- arthroplasty, lumbar, disc
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 367 participants (estimated)
- Lead sponsor
- DePuy SpineIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 22 Sep 2005 (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.
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
Detailed description
This study is an extension out to 5 year follow-up of a randomized comparative IDE trial of the CHARITÉ™ Artificial Disc vs. ALIF with the BAK cage for treatment of degenerative disc disease. The original 2-year trial demonstrated non-inferiority of the CHARITÉ™ compared to ALIF.
This extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training- CHARITE | – | Device: CHARITENon-Randomized Training (TDR with CHARITE) |
| CHARITE | – | Device: CHARITERandomized Subjects treated by Lumbar Total Disc Replacment with CHARITE |
| Control | – | –Randomized Subjects treated by ALIF with BAK cage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Participated in either the training or randomized arm of the CHARITÉ Artificial Disc IDE study,
- Still have the original implant they received in their index surgery.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CHARITELumbar Total Disc Replacement | Device | CHARITE, Training- CHARITE |
Primary outcome
Overall Success
Time frame: 5 Years
ODI Improvement greater than or equal to 15 points from baseline No device failures (i.e., revision, re-operation, supplemental fixation, or removal) No major complications Maintenance or improvement in neurological status compared to baseline.
1 secondary outcome
Secondary Endpoints
Time frame: 5 Years
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 13 Apr 2015.
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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.
Daniel H Stoutenburgh study director
DePuy Spine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by DePuy Spine at 10 sites in United States.
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: finished, as of the sponsor's last update on 13 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Overall Success (time frame: 5 Years). 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 13 Apr 2015.