Columbia

Researchers are evaluating the INHANCE Stemless Reverse Cementless Total Shoulder in a 2:1 randomized, controlled, multi-center, prospective study. The trial aims to assess the effectiveness and safety of this stemless reverse shoulder replacement for individuals with severely painful and disabling arthritic shoulder joints, including osteoarthritis, post-traumatic arthritis, and rotator cuff arthropathy. The study focuses on achieving non-inferiority in shoulder function improvement and ensuring no significant safety issues related to implant revision, radiolucent lines, or component migration within two years after surgery. Participants will receive an uncemented reverse total shoulder implant designed to replace the arthritic joint without using a stemmed component. The study involves a comparison of system components implanted in suitable candidates who have a functional deltoid muscle and adequate bone quality. The treatment is delivered surgically, and participants will be followed for at least two years post-operation. The trial includes assessments of implant stability, such as radiolucent lines and migration or tilt of the humeral and glenoid components. During the study, participants will be monitored before surgery and at two years after surgery using the Constant Murley Score to measure shoulder function. Researchers will also track any removals, revisions, reoperations, or supplemental fixation of implant components. Imaging will be used to evaluate bone-implant interface and component positioning. Participants must complete questionnaires about their outcomes and attend follow-up visits as per the protocol. The total participation time includes pre-operative screening and a two-year post-operative follow-up period for safety and effectiveness evaluation.

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.