King of Prussia

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 safety and pain relief effects of the ReneuRx device compared to corticosteroid injections in adults aged 22 to 80 with moderate to severe chronic lateral hip pain. This study focuses on individuals with Greater Trochanteric Pain Syndrome who have persistent pain despite previous conservative treatments. The trial aims to better understand how these interventions perform in managing ongoing hip pain. Participants are randomly assigned to receive either the ReneuRx device injection around the femoral nerve branches near the hip or a corticosteroid injection consisting of a 40mg Triamcinolone dose mixed with saline. The study uses a parallel design with single masking to compare these two treatments. Treatments are administered once, and participants are followed up for effectiveness and safety over several months. During the study, participants attend multiple visits to complete quality of life questionnaires and pain assessments at baseline and various time points up to 12 months post-treatment. Researchers will monitor both the effectiveness of pain relief and any safety concerns throughout the study period. Total follow-up spans approximately 6 to 12 months after treatment to gather comprehensive data on outcomes and participant experience.