Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7 Clinical Trial
Official title:
Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
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.
| Status | Active, not recruiting |
| Enrollment | 50 |
| Est. completion date | July 2017 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 21 Years to 65 Years |
| Eligibility |
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 (=15ยบ 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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Universitatsklinikum Bonn | Bonn | |
| Germany | Stadtisches Klinikum Gorlitz | Gorlitz | |
| Germany | Stadtisches Klinikum Karlsruhe | Karlsruhe | |
| Switzerland | Klinik St. Anna | Luzern | |
| Switzerland | Spine Center Rischke | Zurich |
| Lead Sponsor | Collaborator |
|---|---|
| AxioMed Spine Corporation |
Germany, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety of FCD | Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD. | 6 months | Yes |
| Primary | Performance of FCD | Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period. | 6 months | No |
| Secondary | Incidence of AEs | Examine the incidence of adverse events including device revision, removal or supplemental fixation through the 2-years post-operative period. | 2 year | Yes |
| Secondary | Neck/Arm Pain | Examine changes in neck and arm pain throughout the 2-years post-operative period. | 2 years | No |
| Secondary | Neurological function | Examine changes in subject neurological function throughout the 2-years post-operative period. | 2 years | No |
| Secondary | Subject Function | Examine changes in subject function throughout the 2-years post-operative period. | 2 years | No |
| Secondary | Radiographic Measurements | Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years. | 2 years | No |
| Secondary | Examine AEs | Examine all adverse events throughout the 2-years post-operative period | 2 years | Yes |