Granger

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 Persona Revision Knee System in patients who have previously undergone primary or revision total knee arthroplasty TKA. This observational study aims to assess the devices performance, clinical benefits, and safety through a retrospective cohort with prospective follow-up. The study involves patients treated with this knee system at up to 20 sites, with a maximum enrollment of 380 participants. The study includes patients implanted with various configurations of the Persona Revision Knee System, including different tibial stems, tibial components, articular surfaces, and femoral components. Participants are identified retrospectively and then invited to participate in prospective data collection at 1, 2, 3, 4, 5, 7, and 10 years after surgery. The device and any compatible instruments used follow the approved instructions for use. Participants will provide data through scheduled follow-up visits over several years, with assessments including the Knee Society Clinical Rating System objective knee score at 2 years as the primary outcome. Secondary measures include adverse events, pain scores, and knee function scores. The study monitors safety and clinical outcomes over time, with a total participation duration potentially extending up to 10 years postoperatively.