Clinical trial NCT00637312: Advent™ Cervical Disc Versus ACDF for Treatment of One Level Degenerative Disc Disease (IDE Study)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Degenerative Disc Disease
Lead sponsor: Orthofix Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-17
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Primary outcomes:
measure: Evaluation of Device and/or Procedure Related Adverse Event(s)
timeFrame: At 24-months
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Shreveport
country: United States
facility: Spine Institute of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: Brain and Spine Specialist
state: Maryland
city: Camden
country: United States
facility: Cooper University Neurological Institute
state: New Jersey
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Triangle Orthopaedics Associates, P.A.
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania, Department of Neurosurgery
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Johnson City
country: United States
facility: East Tennessee Brain and Spine Center
state: Tennessee
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
city: San Antonio
country: United States
facility: The San Antonio Orthopaedic Group
state: Texas
Study officials:
affiliation: Texas Back Institute
name: Scott L Blumenthal, M.D.
role: STUDY_DIRECTOR
References: