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Found 2 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are reviewing anonymous medical records from multiple centers to understand the outcomes of different treatments for chronic pain. This study includes several groups to assess how various approaches work in distinct patient subgroups. The focus is on patients who have had or may have spinal cord stimulation systems or other treatments like radiofrequency RF or intradiscal therapies IDS. The study looks at patients who have previously received spinal cord stimulation or other therapies and those who have switched to different treatments afterward. Treatments under review include Boston Scientific devices and non-Boston Scientific systems such as spinal cord stimulation, RF, and IDS. The data is retrospective, meaning it examines past patient experiences without introducing new treatments. Participants involvement consists of the analysis of their de-identified medical charts, with no active treatment or visits required. Researchers will measure responder rates approximately two years from the start of data collection to evaluate treatment outcomes. The study spans from April 2012 to December 2030, focusing on long-term clinical results in chronic pain management.