Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)

NCT ID: NCT00637312

Last Updated: 2014-03-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2013-02-28

Brief Summary

The purpose of this study is to establish the safety and effectiveness of the Advent™ Cervical Disc compared to Anterior Cervical Discectomy and Fusion (ACDF) in treating degenerative disc disease at a single-level in the cervical spine (from C3 to C7) following cervical discectomy in skeletally mature patients (at least 18 years of age).

Detailed Description

Following surgery study subjects will be evaluated at the following intervals: 6 wks (± 2wks); 3 Months (±2 wks); 6 Month (±1 months); 12 and 24 Month (±2 months) and annually until the last subject enrolled completes their 24 Month follow-up

Conditions

Cervical Degenerative Disc Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Advent™ Cervical Disc

Cervical artificial disc replacement: Advent™ Cervical Disc

Group Type: EXPERIMENTAL

Cervical Artificial Disc (Advent™ Cervical Disc)

Intervention Type: DEVICE

Advent™ Cervical Disc

Standard care - Control

Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System

Group Type: ACTIVE_COMPARATOR

Hallmark™ Anterior Cervical Plate System

Intervention Type: DEVICE

Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)

Interventions

Cervical Artificial Disc (Advent™ Cervical Disc)

Advent™ Cervical Disc

Intervention Type: DEVICE

Hallmark™ Anterior Cervical Plate System

Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)

Intervention Type: DEVICE

Other Intervention Names

Advent™ Cervical Disc

Eligibility Criteria

Inclusion Criteria

• One cervical spine level between C3 and C7 which requires surgical treatment for intractable cervical radiculopathy and/or myelopathy demonstrated by herniated disc, and/or osteophyte formation leading to nerve root and/or spinal cord compression confirmed by patient history (e.g. neck and/or arm pain), functional and/or neurological deficit (e.g. numbness, weakness, diminished or pathologic reflexes, gait disturbances, etc.) and radiographic studies (e.g. CT, MRI, x-rays, etc.).
• Unresponsive to conservative care over a period of at least 6 weeks
• Neck Disability Index score ≥ 15/50 (30%)
• Willing and able to comply with the requirements of the protocol including follow-up requirements and to sign a study specific informed consent

Exclusion Criteria

• More than 1 level requiring surgical treatment for intractable cervical radiculopathy and/or myelopathy.
• Active local (at the proposed surgical site) or systemic infection
• Prior anterior neck surgery at any level.
• Prior posterior cervical spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved.
• Currently undergoing treatment for disease of the thoracic or lumbar spine.
• Axial neck pain as the primary diagnosis, without evidence of neural compression
• Significant cervical anatomical deformity
• Any anatomical consideration which in the investigators opinion would make the anterior cervical approach excessively risky or impossible
• Severe obesity defined as a Body Mass Index (BMI) > 40
• Instability on AP, lateral neutral or flex/ext images: ≥2mm translation relative to the adjacent segment, and/or ≥ 11 degrees relative to adjacent segments
• Central disc height ≤ 2mm
• Advanced spondylosis (i.e. facet joints degeneration, anterior or posterior bridging of the interspace or lack of motion on the pre-operative flexion/extension x-rays)
• Severe cervical myelopathy as indicated by: Signs and/or symptoms > 6months duration, Nurick's Classification grades IV or V, and/or Myelomalacia as evidence on a MRI
• Metabolic bone disease such as osteoporosis to a degree that spinal instrumentation is contra-indicated (Males over 55 years of age, females over 50 years of age and/or subjects that in the investigators opinion are medical indicative of osteoporosis (e.g. early menopause, steroid use, etc.) are required to have a DEXA scan; If the DEXA scan is ≤ -2.5t in the spine, the patient must be excluded)
• Allergy to any component of the device (titanium, polycarbonated polyurethane, polyethylene terephthalate, or ethylene oxide residuals)
• Chronic steroid or other medication use that may interfere with bony/soft tissue healing
• History of endocrine or metabolic disorders (e.g. Paget's disease) known to effect bone and mineral metabolism
• Autoimmune diseases e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
• Insulin dependent diabetes mellitus
• Active malignancy
• Currently pregnant or considering becoming pregnant during the follow-up period
• Advanced emphysema, Alzheimer's disease or other medical conditions that would interfere with patient self-assessment of function, pain or quality of life
• Medical condition (e.g. unstable cardiac disease, end-stage cancer) that may result in patient death prior to study completion
• Chemical dependency (e.g. alcohol or narcotic addiction) problem that may interfere with study requirements
• Mental incompetence as determined by the Investigator which may effect participation in the study
• Incarcerated
• Involved in any current or pending litigation relating to a spinal condition
• Concurrently participating in any other investigational study
• Anatomy (e.g. endplate dimensions) at the index level not consistent with the dimensions of the implants available (e.g. based on pre-operative radiographic evaluations and templates in the surgical technique manual).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthofix Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott L Blumenthal, M.D.

Role: STUDY_DIRECTOR

Texas Back Institute

Locations

University of California Davis

Sacramento, California, United States

Boulder Neurosurgical Associates

Boulder, Colorado, United States

University of South Florida

Tampa, Florida, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

Brain and Spine Specialist

Baltimore, Maryland, United States

Cooper University Neurological Institute

Camden, New Jersey, United States

University of Rochester Medical Center

Rochester, New York, United States

Triangle Orthopaedics Associates, P.A.

Durham, North Carolina, United States

University of Pennsylvania, Department of Neurosurgery

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

East Tennessee Brain and Spine Center

Johnson City, Tennessee, United States

Texas Back Institute

Plano, Texas, United States

The San Antonio Orthopaedic Group

San Antonio, Texas, United States

Countries

United States

Other Identifiers

CP-01003

Identifier Type: -

Identifier Source: org_study_id