Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease

AxioMed

Status

Unknown

Conditions

Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7

Treatments

Device: Freedom Cervical Disc

Study type

Interventional

Funder types

Industry

Identifiers

NCT01763619

PR-300

Details and patient eligibility

About

This study will collect clinical and radiographic data on the Freedom Cervical Disc to monitor the device's safety and performance as part of a post-market evaluation.

Enrollment

50 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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