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

Cervical Disc Degenerative Disorder Clinical Trial

— NeoDisc™  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478088
• Other study ID #: NUVA-ND-0501
• Status: Completed
• Phase: N/A
• First received: May 22, 2007
• Last updated: May 30, 2012
• Start date: September 2006
• Est. completion date: March 2012

Study information

• Verified date: May 2012
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 488
• Est. completion date: March 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cervical Disc Degenerative Disorder
• Intervertebral Disc Degeneration

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Central Texas Spine Institute	Austin	Texas
United States	Center for Advanced Orthopaedics/Adena Health Pavillon	Chillicothe	Ohio
United States	Neurological Associates	Columbus	Ohio
United States	Spine Colorado / Durango Orthopedic Associates	Durango	Colorado
United States	Orthopedic Spine Associates	Eugene	Oregon
United States	Florida Spine Specialists	Ft. Lauderdale	Florida
United States	Florida Research Network, LLC	Gainsville	Florida
United States	OrthoIndy	Indianapolis	Indiana
United States	Lyerly Baptist	Jacksonville	Florida
United States	Spine Midwest, Inc	Jefferson City	Missouri
United States	San Diego Center for Spinal Disorders	La Jolla	California
United States	Western Regional Spine Center for Brain and Spine Surgery	Las Vegas	Nevada
United States	Rocky Mountain Spine Arthroplasty (RMA Ortho)	Loveland	Colorado
United States	Diagnostic and Interventional Surgical Center	Marina del Rey	California
United States	Southern Oregon Orthopedics	Medford	Oregon
United States	Coastal Spine	Mount Laurel	New Jersey
United States	Capital Neurosurgery	Raleigh	North Carolina
United States	Salt Lake Orthopaedic Clinic	Salt Lake City	Utah
United States	The Spine Institute	Santa Monica	California
United States	Optim Healthcare	Savannah	Georgia
United States	OAD Orthopaedics	Warrenville	Illinois
United States	Central Ohio Neurological Surgeons	Westerville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes