Cervical Disc Degenerative DisorderNeoDisc™NCT00478088
Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease
A study testing NeoDisc and Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in people with Cervical Disc Degenerative Disorder, run by NuVasive at 22 sites in United States.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Disc Degenerative Disorder
- What is being tested?
- NeoDisc and Instrumented Anterior Cervical Discectomy and Fusion (ACDF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 22 sitesUnited States
- Study dates
- Sep 2006to Mar 2012
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 years of age (inclusive and skeletally mature)
- Diagnosis of symptomatic cervical disc disease, defined as image- confirmed pathology: herniated disc, spondylosis, and/or loss of disc height. Spondylosis is defined as MRI or CT-confirmed disc dessication, loss of disc height, bridging osteophytes, and/or uncovertebral arthrosis. Loss of disc height is specified as a measurement of at least 25% less than an adjacent nonsymptomatic level, but with a minimum of 1mm height remaining.
- Functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution)
- Symptomatic level is C3-4, C4-5, C5-6 or C6-7 (one level)
- Preop NDI ≥30 points
- Unresponsive to conservative treatment for ≥6 wks, or exhibits progressive symptoms or signs of nerve root or spinal cord compression in the face of conservative treatment
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- Not pregnant, nor interested in becoming pregnant within the follow-up period of the study
- Willing and able to comply with the requirements defined in the protocol for the duration of the study
- Signed and dated Informed Consent
Who cannot join
- Prior cervical fusion surgery at the operative level
- Prior cervical laminectomy at the operative level (prior cervical laminotomy need not be excluded)
- Prior cervical complete facetectomy at the operative level
- Requiring surgical treatment that would leave the patient with a postoperative deficiency of the posterior elements
- Radiographic signs of significant instability at operative level (greater than 3mm translation, > 11 degrees rotation different from adjacent level)
- Bridging osteophytes or motion < 2 degrees
Show all 28Show fewer
- Radiographic confirmation of significant facet joint disease or degeneration
- Chronic neck or arm pain of unknown etiology
- Clinically significant symptomatic myelopathy (e.g., those with signal changes in the spinal cord on preoperative T2-weighted MRI)
- Cervical fracture, anatomic anomaly, or deformity (e.g. ankylosing spondylitis, scoliosis) at the levels to which the prosthesis will be attached
- Severe spondylolisthesis (>grade 1)
- Endocrine disorders or connective tissue diseases
- Rheumatoid arthritis or other autoimmune disease
- Progressive neuromuscular disease, e.g., muscular dystrophy, multiple sclerosis
- Chronic steroid users
- Taking any medications or drugs that are known to potentially interfere with the bone metabolism or soft tissue healing, which may include (but is not limited to) the following: inhaled glucocorticoids for asthma, corticosteroids, thyroid hormones, blood thinners (heparin, warfarin), gonadotropin-releasing hormone agonists for prostate cancer treatment, contraceptive medroxyprogesterone, lithium for bi-polar disorder treatment, anticonvulsants, aluminum-containing antacids, tetracycline
- Osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated (DEXA T-score less than or equal to -2.5; DEXA necessary only if patient exhibits risk factors for low bone mass as quantified in DEXA screening questionnaire).
- Diabetes mellitus requiring insulin management
- Presence of metastases or active spinal tumor malignancy
- Body Mass Index (BMI) > 40
- Active local or systemic infection, including AIDS, hepatitis
- Having been enrolled in another investigational device study within the last 90 days
- Having had another cervical device implanted that would interfere with the surgical approach, study or control device, or follow-up evaluations.
- Demonstrates signs of nonorganic behavior, such as Waddell's signs
- History of substance abuse
- Involved in spinal litigation
- Mentally incompetent
- Incarcerated
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Central Texas Spine Institute
Austin, Texas, 78731
Center for Advanced Orthopaedics/Adena Health Pavillon
Chillicothe, Ohio, 45601
Neurological Associates
Columbus, Ohio, 43221
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, 81301
Orthopedic Spine Associates
Eugene, Oregon, 97401
Florida Spine Specialists
Fort Lauderdale, Florida, 33308
Florida Research Network, LLC
Gainesville, Florida, 32605
OrthoIndy
Indianapolis, Indiana, 46278
Lyerly Baptist
Jacksonville, Florida, 32207
Spine Midwest, Inc
Jefferson City, Missouri, 65101
San Diego Center for Spinal Disorders
La Jolla, California, 92037
Western Regional Spine Center for Brain and Spine Surgery
Las Vegas, Nevada, 89109
Rocky Mountain Spine Arthroplasty (RMA Ortho)
Loveland, Colorado, 80538
Diagnostic and Interventional Surgical Center
Marina del Rey, California, 90245
Southern Oregon Orthopedics
Medford, Oregon, 97504
Coastal Spine
Mount Laurel, New Jersey, 08054
Capital Neurosurgery
Raleigh, North Carolina, 27609
Salt Lake Orthopaedic Clinic
Salt Lake City, Utah, 82124
The Spine Institute
Santa Monica, California, 90404
Optim Healthcare
Savannah, Georgia, 31405
OAD Orthopaedics
Warrenville, Illinois, 60555
Central Ohio Neurological Surgeons
Westerville, Ohio, 43081
About this study
Official title: A Pivotal, Multi-Center, Randomized, Controlled Trial Evaluating The Safety and Effectiveness of The NeoDisc™ Versus Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in Subjects With Single-Level Cervical Disc Disease
The purpose of the study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.
Read the detailed description
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy. Implantation of the device will result in artificial replacement of a pathologically damaged or surgically removed cervical disc. Use of the device also obviates the need to harvest bone graft from the patient's iliac crest, a common and painful part of current surgical techniques.
The NeoDisc is indicated for cervical spinal arthroplasty in skeletally mature subjects with symptomatic cervical disc disease at one level from C3 to C7. Symptomatic cervical disc disease is defined as image-confirmed herniated disc, spondylosis, and/or loss of disc height, with functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution).
- Conditions
- Cervical Disc Degenerative Disorder
- Being tested
- NeoDisc, Instrumented Anterior Cervical Discectomy and Fusion (ACDF)
- Keywords
- Single Level, Cervical Disc Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoDiscDevice
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
Instrumented Anterior Cervical Discectomy and Fusion (ACDF)Device
Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | NeoDisc Receives: Device: NeoDisc |
| 2 | Active comparator | ACDF Receives: Device: Instrumented Anterior Cervical Discectomy and Fusion (ACDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve in NDI by ≥ 15 pnts at 24 mo compared to Baseline; No device failures requiring revision, re-op or removal; No major complications,i.e.,vascular or neurological injury; Maintenance or improvement of neurologic status
Measured: August 2010
Secondary outcomes (1)
ROM; Fusion/migration of device; SF-36 imp of ≥15% at 24 months comp to Baseline; VAS imp of > 20 mm at 24 months comp to Baseline; Disc ht from lateral x-ray showing maintenance or imp from Baseline at 24
Measured: August 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2007 (estimated)
- Study startSep 2006
- Primary completionAug 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Disc Degenerative DisorderStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 488 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Kitchel, MD, Principal investigator, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00478088
- Sponsor's protocol ID
- NUVA-ND-0501
- Acronym
- NeoDisc™
- Status last verified
- May 2012
- First submitted
- 22 May 2007
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pivotal, Multi-Center, Randomized, Controlled Trial Evaluating The Safety and Effectiveness of The NeoDisc™ Versus Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in Subjects With Single-Level Cervical Disc Disease
- ClinicalTrials.gov ID
- NCT00478088
- Acronym / sponsor ID
- NeoDisc™ / NUVA-ND-0501
- Conditions
- Cervical Disc Degenerative Disorder
- Keywords
- Single Level, Cervical Disc Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 488 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 24 May 2007 (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 study is to evaluate the safety and effectiveness of the NeoDisc compared to anterior cervical discectomy and fusion (ACDF) for the treatment of single-level cervical disc disease, by demonstrating non-inferior comparative results at the 24 month follow-up period pertaining to (1) improvement in the Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.
Detailed description
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy. Implantation of the device will result in artificial replacement of a pathologically damaged or surgically removed cervical disc. Use of the device also obviates the need to harvest bone graft from the patient's iliac crest, a common and painful part of current surgical techniques.
The NeoDisc is indicated for cervical spinal arthroplasty in skeletally mature subjects with symptomatic cervical disc disease at one level from C3 to C7. Symptomatic cervical disc disease is defined as image-confirmed herniated disc, spondylosis, and/or loss of disc height, with functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: NeoDiscNeoDisc |
| 2 | Active comparator | Device: Instrumented Anterior Cervical Discectomy and Fusion (ACDF)ACDF |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18-60 years of age (inclusive and skeletally mature)
- Diagnosis of symptomatic cervical disc disease, defined as image- confirmed pathology: herniated disc, spondylosis, and/or loss of disc height. Spondylosis is defined as MRI or CT-confirmed disc dessication, loss of disc height, bridging osteophytes, and/or uncovertebral arthrosis. Loss of disc height is specified as a measurement of at least 25% less than an adjacent nonsymptomatic level, but with a minimum of 1mm height remaining.
- Functional neurological deficit (i.e., exhibits at least one sign associated with cervical level to be treated, including abnormal reflex, decreased motor strength, abnormal dermatome sensitivity, or pain in a dermatomal distribution)
- Symptomatic level is C3-4, C4-5, C5-6 or C6-7 (one level)
- Preop NDI ≥30 points
Key exclusion criteria (28 listed)
- Prior cervical fusion surgery at the operative level
- Prior cervical laminectomy at the operative level (prior cervical laminotomy need not be excluded)
- Prior cervical complete facetectomy at the operative level
- Requiring surgical treatment that would leave the patient with a postoperative deficiency of the posterior elements
- Radiographic signs of significant instability at operative level (greater than 3mm translation, > 11 degrees rotation different from adjacent level)
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 |
|---|---|---|
| NeoDiscThe NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy. | Device | 1 |
| Instrumented Anterior Cervical Discectomy and Fusion (ACDF)Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate. | Device | 2 |
Primary outcome
Improve in NDI by ≥ 15 pnts at 24 mo compared to Baseline; No device failures requiring revision, re-op or removal; No major complications,i.e.,vascular or neurological injury; Maintenance or improvement of neurologic status
Time frame: August 2010
1 secondary outcome
ROM; Fusion/migration of device; SF-36 imp of ≥15% at 24 months comp to Baseline; VAS imp of > 20 mm at 24 months comp to Baseline; Disc ht from lateral x-ray showing maintenance or imp from Baseline at 24
Time frame: August 2010
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 19 Dec 2025.
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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 Kitchel, MD principal investigator
Medical Monitor
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoDisc and Instrumented Anterior Cervical Discectomy and Fusion (ACDF) in people with Cervical Disc Degenerative Disorder, run by NuVasive at 22 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 9 inclusion and 28 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Improve in NDI by ≥ 15 pnts at 24 mo compared to Baseline; No device failures requiring revision, re-op or removal; No major complications,i.e.,vascular or neurological injury; Maintenance or improvement of neurologic status (time frame: August 2010). 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 19 Dec 2025.