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This research aims to evaluate the safety and effectiveness of the CEM-Cage combined with the CEM-Plate in patients undergoing a two-level anterior cervical discectomy and fusion ACDF. It is a first-in-human, prospective, multi-center, non-randomized, single-arm study involving fifty patients with cervical spine conditions such as radiculopathy or myelopathy. The study is designed to provide important information about the devices performance in treating cervical degenerative disc disease. Participants will undergo a two-level ACDF surgery using the CEM-Plate Anterior Cervical Plating System and the CEM-Cage Cervical Interbody System. After surgery, patients will have follow-up visits at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. These visits include assessments such as quality of life surveys and imaging tests like lateral cervical x-rays to check the device placement and spinal fusion progress. Throughout the study, researchers will monitor for fusion success and overall outcomes, including the absence of serious adverse events or need for additional surgeries at the treated levels. Safety and device-related complications will be tracked for up to 24 months. Participants quality of life and spine function will be regularly evaluated, helping to understand the long-term effects of the device.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.