Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7
Conditions
Keywords
Cervical DDD, DDD, degenerative disc disease, C3-C7
Brief summary
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.
Interventions
DEVICEFreedom Cervical Disc
Sponsors
AxioMed Spine Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of FCD | 6 months | Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD. |
| Performance of FCD | 6 months | Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological function | 2 years | Examine changes in subject neurological function throughout the 2-years post-operative period. |
| Subject Function | 2 years | Examine changes in subject function throughout the 2-years post-operative period. |
| Incidence of AEs | 2 year | Examine the incidence of adverse events including device revision, removal or supplemental fixation through the 2-years post-operative period. |
| Examine AEs | 2 years | Examine all adverse events throughout the 2-years post-operative period |
| Radiographic Measurements | 2 years | Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years. |
| Neck/Arm Pain | 2 years | Examine changes in neck and arm pain throughout the 2-years post-operative period. |
Countries
Germany, Switzerland
Outcome results
None listed