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 @ 3:26 AM
Ignite Modification Date:
2025-12-25 @ 3:26 AM
NCT ID:
NCT02178605
Eligibility Criteria:
Inclusion Criteria:
* Has cervical spine pathology as noted by neck pain with or without arm symptoms, functional deficit and/or neurological deficit, confirmed by patient history, as well as radiographic imaging studies:
* CT, MRI scan, x-ray imaging are to include one or more of the following:
* Instability, as defined by translational motion greater than or equal to 3.5 mm or angular motion greater than 11° at a single segment based upon flexion/extension radiographs.
* Osteophyte formation.
* Decreased disc space height.
* Facet joint degeneration.
* Disc herniation or protrusion.
* Signs or symptoms of spinal cord compression (i.e., myelopathy).
* One or more symptomatic levels of degeneration between C3 and C7.
* Age 18 years of age or older at the time of surgery.
* Has not responded to nonoperative treatments including restricted activity, physical therapy, medications, corticosteroid injections, manipulation, TENS for a period of at least three months.
* If female of childbearing age who is not pregnant or nursing and who agrees to use adequate contraception for at least six months following surgery.
* Is willing and able to comply with the study protocol, sign the patient informed consent form, and able to sign the authorization to disclose health information consent form.
Exclusion Criteria:
* Has a condition which requires postoperative medications that interfere with fusion, such as steroids.
* Has been previously diagnosed with osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
* Has active malignancy.
* Has overt or active bacterial infection, either local or systemic.
* Has fever (temperature greater than 101° Fahrenheit oral at the time of surgery).
* Has a documented titanium alloy allergy or allergy to bovine collagen.
* Is mentally incompetent.
* Has a Waddell sign of inorganic behavior score of 3 or greater.
* Is a prisoner.
* Is an alcohol and/or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse.
* Has a history of autoimmune disease.
* Has a hypersensitivity to protein pharmaceuticals, monoclonal antibodies, gammaglobulin, or collagen.
* Has a history of endocrine of metabolic disorder known to affect osteogenesis.
* Is currently pregnant or plans on becoming pregnant within the six months following the surgical procedure
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02178605
Study Brief:
Protocol Section:
NCT02178605