Addison

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.

Researchers are evaluating the effects of combining repetitive Transcranial Magnetic Stimulation rTMS with Cognitive Processing Therapy CPT to reduce symptoms of combat-related Posttraumatic Stress Disorder PTSD. The study also explores how treatment affects depression, social functioning, and brain activity measured by electroencephalography EEG and magnetic resonance imaging MRI. This trial involves veterans diagnosed with PTSD from Post-911 military conflicts. The study has three groups one receives 1 Hz rTMS to the right dorsolateral prefrontal cortex rDLPFC before each of 12 CPT sessions, another receives sham inactive rTMS before each CPT session, and the third group receives only 1 Hz rTMS once per week over 12 weeks without CPT. Each rTMS session lasts 30 minutes. Participants are randomly assigned to these treatment arms to compare the effects. Participants will undergo assessments before treatment begins, including PTSD symptom severity, neuropsychological tests, EEG, and MRI scans. During treatment, symptom measures are collected at sessions 5 and 9. After treatment, follow-up assessments occur at 1 month, 6 months, and 12 months. EEG is done at 1, 6, and 12 months, and MRI at 6 and 12 months to monitor changes. The main outcome is change in PTSD symptoms measured by a clinician-administered scale at 6 months post-treatment.

This research aims to collect information on the real-world use and clinical outcomes of OssDsignAE bone graft substitutes in patients needing spine fusion surgery. It is a multi-center, prospective, observational registry involving up to 25 US study sites. The study focuses on post-market surveillance to monitor the performance of OssDsignAE products in routine clinical practice for conditions like degenerative disc disease and spinal stenosis. Participants will receive spine fusion surgery using OssDsignAE bone grafts, specifically the OssDsignAE Catalyst device, which is a porous, synthetic calcium phosphate bone void filler. The study plans to recruit about 750 participants initially, who will be followed for up to 24 months B1 90 days after their surgery. This period allows evaluation of the bone fusion process and related outcomes over time. During the study, participants will undergo clinical and radiographic follow-up assessments at various intervals, including 6, 12, and 24 months post-surgery. Researchers will measure the rate of bone fusion at 12 months and monitor quality of life through questionnaires assessing disability and pain, as well as neurological function. Safety will also be reviewed continuously for any device-related adverse events throughout the two-year follow-up period.