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New artificial disc could keep neck moving after surgery

NCT ID NCT00478088

Disease control Sponsor: NuVasive Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new artificial disc called NeoDisc against standard fusion surgery (ACDF) in 488 people with a damaged disc in the neck. The goal was to see if NeoDisc is as safe and effective at relieving pain and improving function over two years. Participants were randomly assigned to receive either the artificial disc or fusion, and researchers tracked neck disability, complications, and nerve function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NeoDisc artificial disc replacement device
What this could lead to
If successful, NeoDisc could offer a motion-preserving alternative to fusion surgery, potentially reducing long-term neck stiffness and adjacent disc problems.
What could go wrong
This is a completed trial, but results may not apply to all patients. Risks include device failure, need for revision surgery, or no better outcomes than standard fusion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

488 people

The number who actually took part.

Start date

Sep 2006

Finished

Mar 2012

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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

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Conditions

The condition(s) this trial relates to.

cervical disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cervical disc degenerative disorder

Contacts and locations

Locations

  • Capital Neurosurgery

    Raleigh, North Carolina, 27609, United States

  • Center for Advanced Orthopaedics/Adena Health Pavillon

    Chillicothe, Ohio, 45601, United States

  • Central Ohio Neurological Surgeons

    Westerville, Ohio, 43081, United States

  • Central Texas Spine Institute

    Austin, Texas, 78731, United States

  • Coastal Spine

    Mount Laurel, New Jersey, 08054, United States

  • Diagnostic and Interventional Surgical Center

    Marina del Rey, California, 90245, United States

  • Florida Research Network, LLC

    Gainesville, Florida, 32605, United States

  • Florida Spine Specialists

    Fort Lauderdale, Florida, 33308, United States

  • Lyerly Baptist

    Jacksonville, Florida, 32207, United States

  • Neurological Associates

    Columbus, Ohio, 43221, United States

  • OAD Orthopaedics

    Warrenville, Illinois, 60555, United States

  • Optim Healthcare

    Savannah, Georgia, 31405, United States

  • OrthoIndy

    Indianapolis, Indiana, 46278, United States

  • Orthopedic Spine Associates

    Eugene, Oregon, 97401, United States

  • Rocky Mountain Spine Arthroplasty (RMA Ortho)

    Loveland, Colorado, 80538, United States

  • Salt Lake Orthopaedic Clinic

    Salt Lake City, Utah, 82124, United States

  • San Diego Center for Spinal Disorders

    La Jolla, California, 92037, United States

  • Southern Oregon Orthopedics

    Medford, Oregon, 97504, United States

  • Spine Colorado / Durango Orthopedic Associates

    Durango, Colorado, 81301, United States

  • Spine Midwest, Inc

    Jefferson City, Missouri, 65101, United States

  • The Spine Institute

    Santa Monica, California, 90404, United States

  • Western Regional Spine Center for Brain and Spine Surgery

    Las Vegas, Nevada, 89109, United States

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