Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease
NCT ID: NCT00478088
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
488 participants
INTERVENTIONAL
2006-09-30
2012-03-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
NeoDisc
NeoDisc
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
2
ACDF
Instrumented Anterior Cervical Discectomy and Fusion (ACDF)
Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.
Interventions
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NeoDisc
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
Instrumented Anterior Cervical Discectomy and Fusion (ACDF)
Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
ALL
Yes
Sponsors
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NuVasive
INDUSTRY
Responsible Party
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Principal Investigators
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Scott Kitchel, MD
Role: PRINCIPAL_INVESTIGATOR
Medical Monitor
Locations
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San Diego Center for Spinal Disorders
La Jolla, California, United States
Diagnostic and Interventional Surgical Center
Marina del Rey, California, United States
The Spine Institute
Santa Monica, California, United States
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, United States
Rocky Mountain Spine Arthroplasty (RMA Ortho)
Loveland, Colorado, United States
Florida Spine Specialists
Fort Lauderdale, Florida, United States
Florida Research Network, LLC
Gainesville, Florida, United States
Lyerly Baptist
Jacksonville, Florida, United States
Optim Healthcare
Savannah, Georgia, United States
OAD Orthopaedics
Warrenville, Illinois, United States
OrthoIndy
Indianapolis, Indiana, United States
Spine Midwest, Inc
Jefferson City, Missouri, United States
Western Regional Spine Center for Brain and Spine Surgery
Las Vegas, Nevada, United States
Coastal Spine
Mount Laurel, New Jersey, United States
Capital Neurosurgery
Raleigh, North Carolina, United States
Center for Advanced Orthopaedics/Adena Health Pavillon
Chillicothe, Ohio, United States
Neurological Associates
Columbus, Ohio, United States
Central Ohio Neurological Surgeons
Westerville, Ohio, United States
Orthopedic Spine Associates
Eugene, Oregon, United States
Southern Oregon Orthopedics
Medford, Oregon, United States
Central Texas Spine Institute
Austin, Texas, United States
Salt Lake Orthopaedic Clinic
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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NUVA-ND-0501
Identifier Type: -
Identifier Source: org_study_id