Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
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ClinicalTrials.gov Identifier: NCT01763619
Recruitment Status : Unknown
Verified July 2016 by AxioMed Spine Corporation. Recruitment status was: Active, not recruiting
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Ages Eligible for Study:
21 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Skeletally mature males or females, aged 21 to 65 years old, inclusive.
Single, or adjacent, 2-level degenerative disc disease at C3-C7, inclusive.
Subject is a surgical candidate for an anterior approach to the cervical spine.
Minimum of 6 weeks of unsuccessful conservative treatment.
Subject with at least moderate preoperative pain and functional impairment
Subject is mentally and physically able to comply with protocol, postoperative compliance instructions, and follow-up schedule through 2-years.
Subject must understand and sign the written Informed Consent form.
Subject with axial neck pain only who does not demonstrate concurrent arm pain or progressive neurological deterioration (specifically numbness or muscle weakness in the arm).
An active infection at the operative site or active systemic infection at the time of surgery.
Known or suspected allergy to titanium, polyurethane, cobalt, chromium, molybdenum or silicone.
Previous spinal fusion at the involved, or adjacent, cervical level(s).
Congenital or acquired structural defect at the operative levels (s) or their immediately adjacent level(s).
Significant osteoporosis in the cervical spine.
The investigator should assess if the subject has any of the following conditions at the index or adjacent level(s) which excludes the subject from study participation:
Cervical facet degeneration of the involved C3-C7 levels.
Previous trauma to, or fusion in, the C3-C7 levels.
Cervical instability at the index level(s) on neutral lateral or flexion/extension x-rays.
Radiographic findings of a fused or total collapsed disc.
Significant global cervical kyphosis (≥15º on Cobb angle measurement) or significant reversal of lordosis.
Female of childbearing potential, pregnant, breast feeding, or interested in becoming pregnant in the next two years