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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Universitatsklinikum Bonn
Bonn, Germany
Stadtisches Klinikum Gorlitz
Görlitz, Germany
Stadtisches Klinikum Karlsruhe
Karlsruhe, Germany
Klinik St. Anna
Lucerne, Switzerland
Spine Center Rischke
Safety of FCD
Monitor the safety (operative and post-operative adverse events through 6-months) of the FCD.
Time frame: 6 months
Performance of FCD
Monitor the performance (radiographic evaluation of segmental non-fusion and device function) of the FCD through 6-months post-operative period.
Time frame: 6 months
Incidence of AEs
Examine the incidence of adverse events including device revision, removal or supplemental fixation through the 2-years post-operative period.
Time frame: 2 year
Neck/Arm Pain
Examine changes in neck and arm pain throughout the 2-years post-operative period.
Time frame: 2 years
Neurological function
Examine changes in subject neurological function throughout the 2-years post-operative period.
Time frame: 2 years
Subject Function
Examine changes in subject function throughout the 2-years post-operative period.
Time frame: 2 years
Radiographic Measurements
Examine changes in radiographic measurements of the target, adjacent and cervical segment levels from discharge through the 2-years.
Time frame: 2 years
Examine AEs
Examine all adverse events throughout the 2-years post-operative period
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Zurich, Switzerland
Time frame: 2 years