Keller

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 outcomes of combining the Adductoplasty12 and Lapiplastyae Procedures for patients who need surgery to correct metatarsus adductus and hallux valgus. This study aims to assess how well these procedures improve quality of life and reduce pain, as well as to determine if they effectively correct and maintain the alignment of the first three metatarsals, hallux position, sesamoid position, and foot width. The trial is a prospective, multicenter, unblinded study involving up to 80 participants aged 14 years and older with symptomatic conditions. Participants will undergo the combined Adductoplasty12 and Lapiplastyae Procedures, which involve surgical correction of foot deformities. The study duration extends up to five years following the initial surgery. There are no comparator groups mentioned as this is a single arm intervention study conducted across multiple clinical sites. The procedures are performed under general anesthesia, and patients must be able to adhere to postoperative care instructions. During the study, participants will be assessed at various intervals up to 60 months after the procedure. Evaluations include radiographic imaging to check for recurrence of deformities, measurement of pain and quality of life changes, range of motion, foot width, and monitoring of clinical complications. Weight-bearing recovery times and return to unrestricted activity will also be tracked. These outcomes will help researchers understand the effectiveness and durability of the combined surgical approach.