Freedom® Cervical Disc Use In The Treatment of Cervical Degenerative Disc Disease
- Conditions
- Symptomatic Cervical Degenerative Disc Disease (DDD) From C3-C7
- Registration Number
- NCT01763619
- Lead Sponsor
- AxioMed Spine Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Neck/Arm Pain 2 years Examine changes in neck and arm pain throughout the 2-years post-operative period.
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.
Radiographic Measurements 2 years Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years.
Examine AEs 2 years Examine all adverse events throughout the 2-years post-operative period
Trial Locations
- Locations (5)
Universitatsklinikum Bonn
🇩🇪Bonn, Germany
Stadtisches Klinikum Gorlitz
🇩🇪Gorlitz, Germany
Stadtisches Klinikum Karlsruhe
🇩🇪Karlsruhe, Germany
Klinik St. Anna
🇨🇭Luzern, Switzerland
Spine Center Rischke
🇨🇭Zurich, Switzerland
Universitatsklinikum Bonn🇩🇪Bonn, Germany