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

NCT00478088 | Completed DMC

• 1 other identifier: NUVA-ND-0501
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 22

Brief 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 Neck Disability Index (NDI) score, (2) revision/reoperation/removal rate, (3) complication rate, and (4) maintenance or improvement in neurologic status.

Conditions

Cervical Disc Degenerative Disorder

Keywords

Single Level; Cervical Disc Disease

Outcome Measures

Primary Outcomes (1)

• 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

  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

  August 2010

Study Arms (2)

1

EXPERIMENTAL

NeoDisc

Device: NeoDisc

2

ACTIVE COMPARATOR

ACDF

Device: Instrumented Anterior Cervical Discectomy and Fusion (ACDF)

Interventions

NeoDisc DEVICE

The NeoDisc is an artificial cervical intervertebral disc replacement intended for clinical use following a discectomy.

1

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.

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NuVasive: lead

Study Sites (22)

San Diego Center for Spinal Disorders

La Jolla, California, 92037, United States

Location

Diagnostic and Interventional Surgical Center

Marina del Rey, California, 90245, United States

Location

The Spine Institute

Santa Monica, California, 90404, United States

Location

Spine Colorado / Durango Orthopedic Associates

Durango, Colorado, 81301, United States

Location

Rocky Mountain Spine Arthroplasty (RMA Ortho)

Loveland, Colorado, 80538, United States

Location

Florida Spine Specialists

Fort Lauderdale, Florida, 33308, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

Lyerly Baptist

Jacksonville, Florida, 32207, United States

Location

Optim Healthcare

Savannah, Georgia, 31405, United States

Location

OAD Orthopaedics

Warrenville, Illinois, 60555, United States

Location

OrthoIndy

Indianapolis, Indiana, 46278, United States

Location

Spine Midwest, Inc

Jefferson City, Missouri, 65101, United States

Location

Western Regional Spine Center for Brain and Spine Surgery

Las Vegas, Nevada, 89109, United States

Location

Coastal Spine

Mount Laurel, New Jersey, 08054, United States

Location

Capital Neurosurgery

Raleigh, North Carolina, 27609, United States

Location

Center for Advanced Orthopaedics/Adena Health Pavillon

Chillicothe, Ohio, 45601, United States

Location

Neurological Associates

Columbus, Ohio, 43221, United States

Location

Central Ohio Neurological Surgeons

Westerville, Ohio, 43081, United States

Location

Orthopedic Spine Associates

Eugene, Oregon, 97401, United States

Location

Southern Oregon Orthopedics

Medford, Oregon, 97504, United States

Location

Central Texas Spine Institute

Austin, Texas, 78731, United States

Location

Salt Lake Orthopaedic Clinic

Salt Lake City, Utah, 82124, United States

Location

Study Officials

• Scott Kitchel, MD

  Medical Monitor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2007
• First Posted: May 24, 2007
• Study Start: September 1, 2006
• Primary Completion: August 1, 2010
• Study Completion: March 1, 2012
• Last Updated: December 19, 2025

Record last verified: 2012-05

Locations

US (22)