Los Gatos

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.

This research aims to evaluate the use and safety of Motiva Implants in people undergoing breast implant procedures. The study focuses on collecting and assessing safety and effectiveness data about these implants after they have been approved and are in general use. It includes participants who have primary breast augmentation, revision breast augmentation, or other aesthetic surgeries, with a focus on female patients aged 22 and older. Participants will receive Motiva Implants as part of their breast surgery or undergo other aesthetic procedures. The study is prospective and non-randomized, with data collected at baseline before surgery, during the operation, and annually for up to 10 years after surgery. Participants who have revision surgery or other aesthetic procedures without implants are also included as control groups to compare outcomes. During the study, participants will have various assessments including medical imaging such as CT, ultrasound, or MRI if medically advised. Researchers will monitor for connective tissue disease signs and symptoms, reproductive complications, cancer diagnoses, local complications, and patient satisfaction over 10 years. The impact of RFID on imaging will also be assessed. Participants will be followed for up to 10 years, providing long-term data on the safety and performance of Motiva Implants.

Researchers are evaluating the safety and effectiveness of a device called CORUS-LX used alongside lumbar interbody fusion surgery for patients with symptomatic degenerative lumbosacral disc disease requiring two-level fusion between L4 and S1. The study compares outcomes between patients receiving standard minimally invasive supplemental posterior fusion and those treated with the CORUS-LX device. The trial aims to determine fusion success, absence of serious device-related events, and avoidance of injections or revision surgery related to back or leg pain. Participants will undergo two-level lumbar interbody fusion surgery at L4-L5 and L5-S1 segments with posterior fusion. One group will receive the CORUS-LX device combined with pedicle screw and rod fixation, while the control group will have standard supplemental posterior fusion with similar fixation. Both groups will have instrumentation placed using navigation technology. After surgery, participants will have follow-up visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months to assess outcomes. During the study, participants will attend these scheduled visits to complete surveys on patient-reported outcomes and undergo standard care procedures. Researchers will collect data from imaging and clinical assessments to measure fusion success and monitor for adverse events. The primary outcomes focus on fusion at treated anatomy and freedom from serious device-related events or injections at 12 months. Additional measures include interbody bone presence, segmental motion, disc height changes, and long-term freedom from injections or revision surgery through 24 months. The study duration extends to 24 months of follow-up after surgery.