Granger

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 performance, clinical benefits, and safety of the Persona Revision Knee System in patients who have previously undergone primary or revision total knee arthroplasty (TKA). This study uses a multicenter, single-arm, retrospective cohort design with prospective follow-up to gather data. The study includes patients with knee conditions such as rheumatoid arthritis, osteoarthritis, traumatic arthritis, and other joint issues treated with this knee system. The study focuses on the Persona Revision Knee System implants and related devices used according to their instructions for use. Patients who had the system implanted will be identified retrospectively and invited for prospective follow-up visits at 1, 2, 3, 4, 5, 7, and 10 years after surgery. The device became commercially available in late 2019, so past treatments follow standard care. Up to 20 sites will participate with a maximum of 380 patients enrolled. Participants will attend scheduled follow-up visits involving clinical evaluations to measure knee function using the 1989 Knee Society Clinical Rating System objective knee score over 2 years. Researchers will monitor performance improvements, safety, and clinical benefits of the knee system. Data collection will help assess patient outcomes and device effectiveness with long-term monitoring planned up to 10 years.