Laguna Woods

Researchers are collecting and evaluating long-term data on clinical and radiographic outcomes to better understand the safety and performance of shoulder arthroplasty over time. This study includes people with various shoulder conditions such as osteoarthritis, osteonecrosis, rotator cuff tears, rheumatoid arthritis, fractures, and infections. The trial will follow participants for at least 10 years, with no early limit on follow-up duration. The study includes patients who are either scheduled for shoulder arthroplasty or have already undergone the procedure. Participants must be skeletally mature and expected to survive at least two years beyond surgery. The study is open-label and multi-center, involving both retrospective and prospective data collection. There are no specific interventions or treatments being compared, as the focus is on observing outcomes after shoulder arthroplasty. Participants will undergo assessments including clinical and radiographic evaluations at an average of once per year throughout the study. Outcome measures include the Constant score, ASES (American Shoulder and Elbow Surgeons) score, Oxford Score (optional in the UK), TESS, and MSTS scores related to pre-operative conditions. Researchers will monitor participants for safety and implant performance during the long-term follow-up, which can last a minimum of 10 years.

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.