Cervical Degenerative Disc Disease
Conditions
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
Interventions
DEVICECervical Artificial Disc (Advent™ Cervical Disc)
Advent™ Cervical Disc
DEVICEHallmark™ Anterior Cervical Plate System
Hallmark™ Anterior Cervical Plate System with AlloQuent Structural Allograft (corticocancellous allograft bone)
Sponsors
Orthofix Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of Device and/or Procedure Related Adverse Event(s) | At 24-months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Advent™ Cervical Disc Cervical artificial disc replacement: Advent™ Cervical Disc | 72 |
| Standard Care - Control Anterior cervical discectomy and fusion (ACDF) with Hallmark™ Anterior Cervical Plate System | 36 |
| Total | 108 |
Baseline characteristics
| Characteristic | Standard Care - Control | Advent™ Cervical Disc | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 72 Participants | 108 Participants |
| Age, Continuous | 45.6 years STANDARD_DEVIATION 9.1 | 43 years STANDARD_DEVIATION 8.5 | 43.9 years STANDARD_DEVIATION 8.7 |
| Region of Enrollment United States | 36 participants | 72 participants | 108 participants |
| Sex: Female, Male Female | 19 Participants | 36 Participants | 55 Participants |
| Sex: Female, Male Male | 17 Participants | 36 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 58 / 72 | 21 / 36 |
| serious Total, serious adverse events | 16 / 72 | 1 / 36 |
Outcome results
Primary
Evaluation of Device and/or Procedure Related Adverse Event(s)
Time frame: At 24-months
Population: The study was suspended for higher than anticipated adverse events in the treatment group. Enrollment was stopped and patients were followed for 36 months in the Advent treatment group. Agency approval is not being pursued for this device and thus no analysis has been completed.