Evaluating The Safety and Effectiveness of The NeoDisc™ Versus ACDF in Subjects With Single-Level Cervical Disc Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT00478088
First received: May 22, 2007
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Cervical Disc Degenerative Disorder
Device: NeoDisc
Device: Instrumented Anterior Cervical Discectomy and Fusion (ACDF)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by NuVasive:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 488
Study Start Date: September 2006
Study Completion Date: March 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
NeoDisc
Device: NeoDisc
The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.
Active Comparator: 2
ACDF
Device: Instrumented Anterior Cervical Discectomy and Fusion (ACDF)
Surgical removal of the cervical disc, decompression, and anterior implantation of allograft bone with a cervical plate.

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478088

Locations
United States, California
San Diego Center for Spinal Disorders
La Jolla, California, United States, 92037
Diagnostic and Interventional Surgical Center
Marina del Rey, California, United States, 90245
The Spine Institute
Santa Monica, California, United States, 90404
United States, Colorado
Spine Colorado / Durango Orthopedic Associates
Durango, Colorado, United States, 81301
Rocky Mountain Spine Arthroplasty (RMA Ortho)
Loveland, Colorado, United States, 80538
United States, Florida
Florida Spine Specialists
Ft. Lauderdale, Florida, United States, 33308
Florida Research Network, LLC
Gainsville, Florida, United States, 32605
Lyerly Baptist
Jacksonville, Florida, United States, 32207
United States, Georgia
Optim Healthcare
Savannah, Georgia, United States, 31405
United States, Illinois
OAD Orthopaedics
Warrenville, Illinois, United States, 60555
United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States, 46278
United States, Missouri
Spine Midwest, Inc
Jefferson City, Missouri, United States, 65101
United States, Nevada
Western Regional Spine Center for Brain and Spine Surgery
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Coastal Spine
Mount Laurel, New Jersey, United States, 08054
United States, North Carolina
Capital Neurosurgery
Raleigh, North Carolina, United States, 27609
United States, Ohio
Center for Advanced Orthopaedics/Adena Health Pavillon
Chillicothe, Ohio, United States, 45601
Neurological Associates
Columbus, Ohio, United States, 43221
Central Ohio Neurological Surgeons
Westerville, Ohio, United States, 43081
United States, Oregon
Orthopedic Spine Associates
Eugene, Oregon, United States, 97401
Southern Oregon Orthopedics
Medford, Oregon, United States, 97504
United States, Texas
Central Texas Spine Institute
Austin, Texas, United States, 78731
United States, Utah
Salt Lake Orthopaedic Clinic
Salt Lake City, Utah, United States, 82124
Sponsors and Collaborators
NuVasive
Investigators
Principal Investigator: Scott Kitchel, MD Medical Monitor
  More Information

No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT00478088     History of Changes
Other Study ID Numbers: NUVA-ND-0501
Study First Received: May 22, 2007
Last Updated: May 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by NuVasive:
Single Level
Cervical Disc Disease

Additional relevant MeSH terms:
Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 28, 2014