Union

Researchers are evaluating the safety and effectiveness of the CEM-Cage used with the CEM-Plate for patients undergoing a 2-level anterior cervical discectomy and fusion (ACDF) to address neck pain and cervical spine conditions such as spondylosis and radiculopathy. This prospective, first-in-human, multi-center, non-randomized, single-arm study will enroll fifty patients aged 22 to 79 years who have symptomatic cervical degenerative disc disease at two contiguous levels. The study aims to assess both the fusion success and overall surgical success over a 24-month period. Participants will undergo the 2-level ACDF surgical procedure using the CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System. Following surgery, patients will be monitored through a screening period, the operation itself, and six post-operative visits at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months. Imaging tests such as static lateral cervical x-rays at 4 weeks and flexion/extension and neutral lateral radiographs at subsequent visits will help assess implant positioning, fusion, and overall success. Quality of life scales and adverse events will be recorded at each visit. Throughout the study, participants will complete evaluations including imaging, clinical assessments, and quality of life questionnaires to monitor treatment outcomes and safety. Researchers will track fusion rates and surgical success, defined by implant performance, absence of serious adverse events, and no need for further surgery at the treated levels. The total participation lasts 24 months with regular follow-up visits to ensure thorough monitoring of patient progress and device performance.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.