Cervical Degenerative Disc DiseaseNCT00637312
Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)
A study testing Cervical Artificial Disc (Advent™ Cervical Disc) and Hallmark™ Anterior Cervical Plate System in people with Cervical Degenerative Disc Disease, run by Orthofix Inc. at 13 sites in United States.
Trial summary
The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Degenerative Disc Disease
- What is being tested?
- Cervical Artificial Disc (Advent™ Cervical Disc) and Hallmark™ Anterior Cervical Plate System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 13 sitesUnited States
- Study dates
- Mar 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- One cervical spine level between C3 and C7 which requires surgical treatment for intractable cervical radiculopathy and/or myelopathy demonstrated by herniated disc, and/or osteophyte formation leading to nerve root and/or spinal cord compression confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, x-rays, etc.).
- Unresponsive to conservative care over a period of at least 6 weeks
- Neck Disability Index score ≥ 15/50 (30%)
- Willing and able to comply with the requirements of the protocol including follow-up requirements and to sign a study specific informed consent
Who cannot join
- More than 1 level requiring surgical treatment for intractable cervical radiculopathy and/or myelopathy.
- Active local (at the proposed surgical site) or systemic infection
- Prior anterior neck surgery at any level.
- Prior posterior cervical spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved.
- Currently undergoing treatment for disease of the thoracic or lumbar spine.
- Axial neck pain as the primary diagnosis, without evidence of neural compression
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- Significant cervical anatomical deformity
- Any anatomical consideration which in the investigators opinion would make the anterior cervical approach excessively risky or impossible
- Severe obesity defined as a Body Mass Index (BMI) > 40
- Instability on AP, lateral neutral or flex/ext images: ≥2mm translation relative to the adjacent segment, and/or ≥ 11 degrees relative to adjacent segments
- Central disc height ≤ 2mm
- Advanced spondylosis (i.e. facet joints degeneration, anterior or posterior bridging of the interspace or lack of motion on the pre-operative flexion/extension x-rays)
- Severe cervical myelopathy as indicated by: Signs and/or symptoms > 6months duration, Nurick's Classification grades IV or V, and/or Myelomalacia as evidence on a MRI
- Metabolic bone disease such as osteoporosis to a degree that spinal instrumentation is contra-indicated (Males over 55 years of age, females over 50 years of age and/or subjects that in the investigators opinion are medical indicative of osteoporosis (e.g. early menopause, steroid use, etc.) are required to have a DEXA scan; If the DEXA scan is ≤ -2.5t in the spine, the patient must be excluded)
- Allergy to any component of the device (titanium, polycarbonated polyurethane, polyethylene terephthalate, or ethylene oxide residuals)
- Chronic steroid or other medication use that may interfere with bony/soft tissue healing
- History of endocrine or metabolic disorders (e.g. Paget's disease) known to effect bone and mineral metabolism
- Autoimmune diseases e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
- Insulin dependent diabetes mellitus
- Active malignancy
- Currently pregnant or considering becoming pregnant during the follow-up period
- Advanced emphysema, Alzheimer's disease or other medical conditions that would interfere with patient self-assessment of function, pain or quality of life
- Medical condition (e.g. unstable cardiac disease, end-stage cancer) that may result in patient death prior to study completion
- Chemical dependency (e.g. alcohol or narcotic addiction) problem that may interfere with study requirements
- Mental incompetence as determined by the Investigator which may effect participation in the study
- Incarcerated
- Involved in any current or pending litigation relating to a spinal condition
- Concurrently participating in any other investigational study
- Anatomy (e.g. endplate dimensions) at the index level not consistent with the dimensions of the implants available (e.g. based on pre-operative radiographic evaluations and templates in the surgical technique manual).
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Brain and Spine Specialist
Baltimore, Maryland, 21215
Boulder Neurosurgical Associates
Boulder, Colorado, 80304
Cooper University Neurological Institute
Camden, New Jersey, 08103
Medical University of South Carolina
Charleston, South Carolina, 29425
Triangle Orthopaedics Associates, P.A.
Durham, North Carolina, 27704
East Tennessee Brain and Spine Center
Johnson City, Tennessee, 37604
University of Pennsylvania, Department of Neurosurgery
Philadelphia, Pennsylvania, 19107
Texas Back Institute
Plano, Texas, 75093
University of Rochester Medical Center
Rochester, New York, 14642
University of California Davis
Sacramento, California, 95816
The San Antonio Orthopaedic Group
San Antonio, Texas, 78216
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
University of South Florida
Tampa, Florida, 33606
About this study
Official title: Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease
The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age).
Read the detailed description
Following surgery study subjects will be evaluated at the following intervals: 6 wks (± 2wks); 3 Months (±2 wks); 6 Month (±1 months); 12 and 24 Month (±2 months) and annually until the last subject enrolled completes their 24 Month follow-up
- Conditions
- Cervical Degenerative Disc Disease
- Being tested
- Cervical Artificial Disc (Advent™ Cervical Disc), Hallmark™ Anterior Cervical Plate System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical Artificial Disc (Advent™ Cervical Disc)Device
Also called Advent™ Cervical Disc
Advent™ Cervical Disc
Hallmark™ Anterior Cervical Plate SystemDevice
Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)
| Study group | Role | What they receive |
|---|---|---|
| Advent™ Cervical Disc | Experimental | Cervical artificial disc replacement: Advent™ Cervical Disc Receives: Device: Cervical Artificial Disc (Advent™ Cervical Disc) |
| Standard care - Control | Active comparator | Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System Receives: Device: Hallmark™ Anterior Cervical Plate System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Device and/or Procedure Related Adverse Event(s)
Measured: At 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2011
- Study completionFeb 2013
Why it stopped: Greater-than-anticipated rate of revisions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott L Blumenthal, M.D., Study director, Texas Back Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637312
- Sponsor's protocol ID
- CP-01003
- Status last verified
- Feb 2014
- First submitted
- 10 Mar 2008
- Last updated
- 27 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease
- ClinicalTrials.gov ID
- NCT00637312
- Acronym / sponsor ID
- CP-01003
- Conditions
- Cervical Degenerative Disc Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Greater-than-anticipated rate of revisions
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Mar 2008 (estimated)
- Results
- Posted 27 Mar 2014
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 study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age).
Detailed description
Following surgery study subjects will be evaluated at the following intervals: 6 wks (± 2wks); 3 Months (±2 wks); 6 Month (±1 months); 12 and 24 Month (±2 months) and annually until the last subject enrolled completes their 24 Month follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advent™ Cervical Disc | Experimental | Device: Cervical Artificial Disc (Advent™ Cervical Disc)Cervical artificial disc replacement: Advent™ Cervical Disc |
| Standard care - Control | Active comparator | Device: Hallmark™ Anterior Cervical Plate SystemAnterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- One cervical spine level between C3 and C7 which requires surgical treatment for intractable cervical radiculopathy and/or myelopathy demonstrated by herniated disc, and/or osteophyte formation leading to nerve root and/or spinal cord compression confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, x-rays, etc.).
- Unresponsive to conservative care over a period of at least 6 weeks
- Neck Disability Index score ≥ 15/50 (30%)
- Willing and able to comply with the requirements of the protocol including follow-up requirements and to sign a study specific informed consent
Key exclusion criteria (29 listed)
- More than 1 level requiring surgical treatment for intractable cervical radiculopathy and/or myelopathy.
- Active local (at the proposed surgical site) or systemic infection
- Prior anterior neck surgery at any level.
- Prior posterior cervical spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved.
- Currently undergoing treatment for disease of the thoracic or lumbar spine.
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 |
|---|---|---|
| Cervical Artificial Disc (Advent™ Cervical Disc)Also: Advent™ Cervical DiscAdvent™ Cervical Disc | Device | Advent™ Cervical Disc |
| Hallmark™ Anterior Cervical Plate SystemHallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone) | Device | Standard care - Control |
Primary outcome
Evaluation of Device and/or Procedure Related Adverse Event(s)
Time frame: At 24-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Scott L Blumenthal, M.D. study director
Texas Back Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical Artificial Disc (Advent™ Cervical Disc) and Hallmark™ Anterior Cervical Plate System in people with Cervical Degenerative Disc Disease, run by Orthofix Inc. at 13 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 4 inclusion and 29 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 27 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Yes. Results are posted in the registry (first posted 27 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Evaluation of Device and/or Procedure Related Adverse Event(s) (time frame: At 24-months). 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 27 Mar 2014.