Cervical Intervertebral Disc Degeneration Clinical Trial
Official title:
A Randomized Multi-Center Study to Evaluate the Safety and Efficacy of the Cervical I/F Cage for Anterior Cervical Fusion
The purpose of this study is to determine the clinical success of the Cervical I/F Cage in treatment of one or two adjacent levels of degenerative disc disease of the cervical spine compared with standard of care treatment using either autograft, autograft with a plate or allograft with a plate
This is a prospective randomized multi-center clinical trial to assess the safety and
efficacy of the investigational device, Cervical I/F Cage for fusion in one or two adjacent
levels of the cervical spine. Patients will be randomly assigned in a ration of 1:1 between
the investigational and control groups.
Comparison: The device will be compared to a control group consisting of the 3 accepted
standard of care treatments (autograft, autograft with an anterior plate, or allograft with
an anterior plate). For two level fusions, the control group will be limited to autograft
with a plate or allograft with a plate. Based on the current literature, it is believed that
there is no difference between the three treatments in terms of clinical success, fusion
success, or safety issues. However, amongst the investigators there are preferred
treatments. Each investigator will choose one or more of the control treatments at study
initiation. Patients will then be randomized in a 1:1 Cage:control randomization schema.
Approximately 240 subjects will be enrolled at 20 sites. Eligible patients will have
symptomatic degeneration of one or two adjacent cervical discs, have failed six weeks of
non-surgical treatment, have sufficiently severe enough symptoms to warrant surgery, and
have had no prior fusion surgery on the cervical spine.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01832818 -
Post-Market Study Evaluating the Safety and Effectiveness of NuNec® Cervical Arthroplasty System
|
N/A |