Addison

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.

Researchers are evaluating the effects of combining repetitive Transcranial Magnetic Stimulation (rTMS) with Cognitive Processing Therapy (CPT) to treat combat-related Posttraumatic Stress Disorder (PTSD) symptoms in veterans. This study also looks at changes in depression, social functioning, and brain activity using EEG and MRI. It compares three treatment approaches: active rTMS plus CPT, sham rTMS plus CPT, and active rTMS alone. The study randomly assigns veterans with combat-related PTSD to one of three groups. One group receives 1 Hz rTMS to the right dorsolateral prefrontal cortex (rDLPFC) before each of 12 CPT sessions. Another group receives sham rTMS before each CPT session. The third group receives the rTMS treatment alone over 12 sessions. The rTMS device delivers magnetic pulses at 110% of the participant's motor threshold. Participants undergo assessments before treatment, during treatment sessions (at sessions 5 and 9), and after treatment at 1, 6, and 12 months. These include PTSD symptom severity tests, neuropsychological evaluations, EEG, and MRI scans. The main outcome measures focus on changes in PTSD symptoms from baseline to 6 months post-treatment, with ongoing follow-up to monitor safety and effectiveness over time.

Researchers are collecting real-world information on the use and clinical outcomes of OssDsign4 bone graft substitutes in patients needing spine fusion surgery. This multi-center, prospective observational registry study aims to monitor and evaluate patients who receive these commercially available bone grafts, focusing on conditions like degenerative disc disease and spinal stenosis. The study supports post-market surveillance to understand how these bone grafts perform in routine clinical practice. Participants will undergo spine fusion surgery using OssDsign4 bone grafts, such as the OssDsign4 Catalyst, which is an osteoconductive, resorbable, porous, 100% nano synthetic calcium phosphate bone void filler. The study plans to enroll about 450 subjects across up to 15 US sites, with no set end date. After the surgery, patients will be followed for about 24 months 8 90 days to track outcomes. During the study, participants will attend post-operative clinical and radiographic follow-up visits to assess bone fusion and recovery progress. Researchers will gather data on the rate of bone fusion at approximately 12 months post-operation and continue monitoring for up to two years. Patients must be able to comply with study requirements, including follow-up appointments and completing necessary forms, to ensure comprehensive data collection and safety monitoring.