Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 12:12 AM
NCT ID:
NCT00758758
Eligibility Criteria:
Inclusion Criteria:
* The patient qualifies for ACDF based upon physical examination and medical history. The patient has single or two adjacent levels(s) symptomatic cervical disc disease (including disc herniation and/or spondylosis) from the C3-C4 disc to the C7-T1 disc with associated radiculopathy and/or myelopathy due to nerve root and/or spinal cord compression due to herniated nucleus pulposus or osteophyte formation on the posterior vertebral endplates. Patients who are candidates for surgery based on radicular symptoms must have at least one month of conservative treatment prior to inclusion in the study.
* The patient has no history of previous anterior cervical fusion surgery at the involved levels.
* The patient has no history of previous cervical fusion surgery at the adjacent levels.
* The patient is willing and able to provide written informed consent.
* The patient is likely to complete the required follow-up.
Exclusion Criteria:
* The patient is mentally compromised (e.g., under treatment for a psychiatric disorder or has senile dementia or Alzheimer's disease), or has evidence of alcohol or other substance abuse for the previous 12 months.
* The patient has a neuromuscular disorder that would engender unacceptable risk of instability, implant fixation failure, or complications in postoperative care.
* The patient has a diagnosed systemic disease that requires the chronic administration of nonsteroidal anti-inflammatory and steroidal drugs.
* The patient has osteopenia to a degree that would contraindicate spinal instrumentation (borderline osteoporosis).
* The patient has osteoporosis to a degree that would contraindicate spinal instrumentation.
* The patient is unable or unwilling to attend postoperative follow-up visits.
* The patient has received an investigational drug within the previous six months or an investigational device within the previous 12 months.
* The patient has a spinal condition other than Cervical DDD based upon physical examination and medical history.
* The patient has an infection site distant from the involved levels that may spread to the involved levels hematogenously.
* The patient has insufficient bone stock to fix the component.
* The patient has a known sensitivity to metallic implants.
* The patient is a prisoner.
* The patient has a Body Mass Index (BMI) greater than or equal to 40.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00758758
Study Brief:
Protocol Section:
NCT00758758