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

• ClinicalTrials.gov Identifier: NCT00637312
• Recruitment Status: Terminated
• First Posted: March 17, 2008
• Results First Posted: March 27, 2014
• Last Update Posted: March 27, 2014
• Sponsor: Orthofix Inc.
• Information provided by (Responsible Party): Orthofix Inc.

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Cervical Degenerative Disc Disease	Device: Cervical Artificial Disc (Advent™ Cervical Disc); Device: Hallmark™ Anterior Cervical Plate System	Not Applicable

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Trial Comparing the Blackstone Advent™ Cervical Disc to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of One Level Degenerative Disc Disease
• Study Start Date: March 2008
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: February 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: Advent™ Cervical Disc; Cervical artificial disc replacement: Advent™ Cervical Disc	Device: Cervical Artificial Disc (Advent™ Cervical Disc); Advent™ Cervical Disc; Other Name: Advent™ Cervical Disc
Active Comparator: Standard care - Control; Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System	Device: Hallmark™ Anterior Cervical Plate System; Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)

Outcome Measures

Primary Outcome Measures :

1. Evaluation of Device and/or Procedure Related Adverse Event(s) [ Time Frame: At 24-months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

United States, California

University of California Davis

Sacramento, California, United States, 95816

United States, Colorado

Boulder Neurosurgical Associates

Boulder, Colorado, United States, 80304

United States, Florida

University of South Florida

Tampa, Florida, United States, 33606

United States, Louisiana

Spine Institute of Louisiana

Shreveport, Louisiana, United States, 71101

United States, Maryland

Brain and Spine Specialist

Baltimore, Maryland, United States, 21215

United States, New Jersey

Cooper University Neurological Institute

Camden, New Jersey, United States, 08103

United States, New York

University of Rochester Medical Center

Rochester, New York, United States, 14642

United States, North Carolina

Triangle Orthopaedics Associates, P.A.

Durham, North Carolina, United States, 27704

United States, Pennsylvania

University of Pennsylvania, Department of Neurosurgery

Philadelphia, Pennsylvania, United States, 19107

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

United States, Tennessee

East Tennessee Brain and Spine Center

Johnson City, Tennessee, United States, 37604

United States, Texas

Texas Back Institute

Plano, Texas, United States, 75093

The San Antonio Orthopaedic Group

San Antonio, Texas, United States, 78216

Sponsors and Collaborators

Orthofix Inc.

Investigators

• Study Director: Scott L Blumenthal, M.D.; Texas Back Institute

More Information

• Responsible Party: Orthofix Inc.
• ClinicalTrials.gov Identifier: NCT00637312
• Other Study ID Numbers: CP-01003
• First Posted: March 17, 2008
• Results First Posted: March 27, 2014
• Last Update Posted: March 27, 2014
• Last Verified: February 2014

Additional relevant MeSH terms:

Spinal Diseases; Intervertebral Disc Degeneration; Bone Diseases; Musculoskeletal Diseases