Columbia

This clinical trial evaluates the INHANCE Stemless Reverse Cementless Total Shoulder device compared to the INHANCE Stemmed Reverse Total Shoulder for people needing reverse total shoulder replacement due to painful, disabling arthritis or rotator cuff arthropathy. The study aims to assess effectiveness and safety by comparing shoulder function and implant stability over two years after surgery. Participants will be randomly assigned to receive either the stemless or stemmed reverse total shoulder device. The study focuses on measuring shoulder function using the Constant-Murley Score and monitoring for any implant revisions, removals, reoperations, or fixation issues. Safety endpoints include checking for bone radiolucency and implant migration or tilt at two years post-operation. Throughout the study, participants will undergo evaluations before surgery and at multiple follow-up points up to two years, including shoulder function tests and questionnaires about their health and shoulder performance. Researchers will track complications and implant survivorship while ensuring participants complete patient-reported outcome measures. The total study duration extends up to the final two-year assessment after surgery.

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.