Two clinical trials are now enrolling patients to evaluate the BAGUERA C as a new cervical disc replacement option for patients with degenerative cervical disc disease. Each trial will enroll approximately 300 patients at up to 30 study sites in the U.S. The clinical trials will compare the Spineart BAGUERA C to the Zimmer Biomet Mobi-C® Cervical Disc at a single level or at two contiguous levels in the cervical spine.
Patients suffering from symptomatic cervical disc disease affecting one level or two adjacent levels between C3 and C7, and who experience the following signs and symptoms may be candidates:
- Neck or arm pain, and/or
- Functional and/or neurological deficit accompanied by at least one of the following conditions confirmed by MRI or X-Ray:
- Herniated nucleus pulposus; and/ or
- Spondylarthrosis defined by the presence of osteophytes; and/ or
- Reduction of disc height
- Age between 22 to 69
- No response to non-surgical treatment for at least six weeks, or symptoms or signs of progressive root compression despite conservative treatment.