The APEX 3D™ Total Ankle Replacement System is intended to reduce pain and restore motion to a failing ankle joint due to rheumatoid, post-traumatic, or degenerative arthritis. In 2020, the APEX 3D™ Total Ankle Replacement System received 510(K) clearance from the FDA, demonstrating that the device is marketed as safe and effective. The primary objective of this research study is to determine implant survivorship. Enrollment is expected to take approximately one to two years. All subjects will be followed for ten years post-operatively. Study follow-up visits will occur at 6-weeks, 6-months, and annually for ten years after surgery. During the pre-operative visit and each follow-up visit, subjects will be asked to complete a series of questionnaires that assess their levels of pain, function, mobility, and quality of life. Comparison of pre-operative scores to post-operative scores can be used to assess the improvement in patient function, thus supporting the benefit and clinical performance of the intervention. As with any clinical research study, there is a risk of unintended personal health information disclosure.

Imagine you're flipping through a medical journal and stumble upon a study about lung cancer treatment. This study is not just any ordinary research; it's focused on a group often overlooked in clinical trials: older adults. The researchers are curious about how well a new treatment, called immunotherapy, works for these older folks who might have other health issues besides cancer. They've noticed that most studies tend to include younger, healthier people, so they want to see if the same treatments work as well for Grandma and Grandpa. They found that immunotherapy, which boosts the body's immune system to fight cancer, can be a game-changer for older adults with lung cancer. But here's the twist: they're not sure if it's always the best option, especially for those with a certain type of lung cancer marker. So, they're calling for more studies to figure out the best treatment plan for older adults with different levels of this marker. It's like a puzzle they're trying to solve to make sure Grandma and Grandpa get the best care possible.

In this study, all eligible study participants will have a clinically indicated reason to undergo a bronchoscopy procedure, using a EBUS-TBNA scope, before enrolling in the study. EBUS-TBNA stands for "endobronchial ultrasound-guided transbronchial needle aspiration" which is a procedure to collect lymph node tissue from within the lungs by inserting a flexible tube-like camera through the mouth, then down into the lungs.

After providing consent to participate in this study, each subject will be randomly assigned (by chance, like the flip of a coin) to either have or not have a cytopathology technologist (person who looks at samples under a microscope) in the room during your bronchoscopy, and then randomly assigned again (by chance, like the flip of a coin) to either have your tissue specimen prepared with clot or liquid preparation. Clot preparation is placing the tissue biopsy in a gel prior to being viewed under a microscope, whereas liquid preparation is placing the tissue biopsy in a liquid prior to being viewed under a microscope.

It is important to note that, by participating in this study, subjects will still receive the standard of care with a proven track record for obtaining lymph node tissue.

The reason for this research study is to determine whether rapid on-site cytopathologic evaluation, or the clot based method, can increase the chances of gathering adequate tissue for Next Generation Sequencing. Next generation sequencing is a test which detects molecular markers from tissue, or blood, samples and can provide possible treatment options for specific forms of lung cancer.