Eisenberg

Researchers are evaluating the Pheno4U data platform in patients undergoing Total Knee Arthroplasty TKA to collect and analyze implant and patient data. This prospective, multinational pilot study includes adult patients receiving an Aesculap TKA implant, aiming to identify critical risk factors and optimize patient-centered therapies for conditions such as degenerative osteoarthritis and rheumatoid arthritis. Each patient will receive an Aesculap TKA implant as part of their routine clinical care. Data will be gathered through the Pheno4U platform, including patient responses to health questionnaires and measurements of active Range of Motion ROM using the BPMpathway sensor and application. This sensor can also support patients with pre- and postoperative training. Participants will be monitored up to 12 months post-surgery with various assessments, including changes in knee injury and osteoarthritis scores, pain levels, patient satisfaction, and psychological status. The study will track the development of active ROM for up to three months and identify any unknown risks or side effects related to the knee arthroplasty using sensor and app data. The study duration and follow-up are designed to gather comprehensive patient outcome information.

Researchers are investigating the use of CD8 TEMRA cells as a biomarker to predict healing outcomes after fractures, particularly focusing on patients who experience delayed healing or non-union. This prospective study aims to distinguish between normal healing, delayed healing, and pseudarthrosis by measuring the expression of these immune cells before surgery. The goal is to improve early identification of patients at risk for poor healing, which currently lacks reliable prognostic methods and leads to increased interventions, longer hospital stays, and work incapacity. The study involves patients with closed fractures of the humerus-shaft, forearm-shaft, femur, or tibia who undergo osteosynthesis surgery. Blood samples will be taken upon hospital admission to measure preoperative CD8 TEMRA cell levels. Healing progress will be monitored through routine clinical and radiological examinations, including X-rays and CT scans, as well as functional assessments and quality of life questionnaires. Key study endpoints are set at 17-19 weeks for detecting delayed healing and 34-36 weeks for pseudarthrosis, with blinded analysis comparing biomarker levels to actual healing outcomes. Participants will have scheduled visits integrated with their standard clinical care for fracture monitoring. Researchers will collect data using imaging, clinical exams, and patient-reported outcomes like the SF-36 health survey. The main measure is the clinical assessment of fracture consolidation at 19 weeks post-surgery, with a secondary assessment at 36 weeks. This study is designed to validate CD8 TEMRA cells as a predictive marker under routine conditions, potentially guiding individualized treatment strategies to enhance fracture healing.