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

Cervical Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00637312
• Other study ID #: CP-01003
• Status: Terminated
• Phase: N/A
• First received: March 10, 2008
• Last updated: February 12, 2014
• Start date: March 2008
• Est. completion date: February 2013

Study information

• Verified date: February 2014
• Source: Orthofix Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: February 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

Intervention

Device:
• Cervical Artificial Disc (Advent™ Cervical Disc)
Advent™ Cervical Disc
• Hallmark™ Anterior Cervical Plate System
Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)

Locations

Country	Name	City	State
United States	Brain and Spine Specialist	Baltimore	Maryland
United States	Boulder Neurosurgical Associates	Boulder	Colorado
United States	Cooper University Neurological Institute	Camden	New Jersey
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Triangle Orthopaedics Associates, P.A.	Durham	North Carolina
United States	East Tennessee Brain and Spine Center	Johnson City	Tennessee
United States	University of Pennsylvania, Department of Neurosurgery	Philadelphia	Pennsylvania
United States	Texas Back Institute	Plano	Texas
United States	University of Rochester Medical Center	Rochester	New York
United States	University of California Davis	Sacramento	California
United States	The San Antonio Orthopaedic Group	San Antonio	Texas
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	University of South Florida	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Orthofix Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Device and/or Procedure Related Adverse Event(s)		At 24-months	Yes