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Pheno4U®
Pheno4U® is a platform solution aiming at identifying phenotypes in patients to treat each patient type as individual as possible. The focus is on reconstructing the patterns of patient anatomy and kinematic function.
Preoperative risk prediction, advanced phenotyping and kinematic analysis provide crucial decision support in planning of treatment protocol and surgical strategy.
The initial, pre-operative phase focuses on preparation through data acquisition based on four pillars.
The Electronic Health Record feeds the data platform with information on indicators such as Body Mass Index, X-rays, and the like. Our ForPatientApp adds the patient’s medical history, activity and pain scores (using the Knee injury and Osteoarthritis Outcome Score KOOS). The BPMpathway kinematic sensor delivers information on Range of Motion (ROM) and corresponding pain levels. Lastly, the Smart Gait Lab (SGL) provides insights on kinematic and laxity parameters. The resulting unique patient profile allows for individual risk prediction and preoperative phenotyping.
The acquired data is subsequently used for creating a simulation in the planning platform. Based on the preoperative phenotyping, the type and size of implant and and kinematic alignment the surgeon can make a decision how to operate the patient. At the same time, the simulation can highlight potential risks and predict outcomes for more transparent and effective patient communication and preparation.
In the intraoperative phase the Pheno4U® TKA Level 1 software (not CE approved) executed with the OrthoPilot® navigation system leads to the proper execution of the defined surgical strategy. The safety corridor simulation allows a personalized alignment and secures the longevity of the implant.
Most of today’s TKA knee systems are designed and tested for mechanical axis alignment (180° ± 3°). However, all knees are different in alignment and many patients show a hip-knee-angle (HKA) above or under 3° leaving surgeons wondering about the best alignment strategies in TKA. The Pheno4U® model follows a reverse engineering approach: aiming at recreating the initial, individual placement and axis alignment rather than pushing the body to adapt to a standard.
Precise navigation brings the Pheno4U® approach to life. The OrthoPilot® Elite is part of an integrated endoprosthesis system of interacting hardware, software, implants and smart multifunctional instruments – developed to give surgeons exact, continuous guidance and real-time feedback on implant and instrument positions. All surgical steps and results are displayed and automatically documented through a mobile OR assistant.
In surgery, the Pheno4U® OrthoPilot® Elite navigation starts with a pre-incision acquisition of laxity and kinematic parameters, double-checking and complementing the previously collected patient data. A kinematic simulation based on these completed insights allows for the finalization of the personalized plan and its precise execution.
The Post-OP phase focuses on utilizing outcome measures to inform management and enhanced rehabilitation strategies. By closely monitoring patient progress and adapting recovery plans, the goal is to support surgeons in achieving superior post-operative results and facilitating quicker, more effective patient recovery.
Postoperatively, data acquisition tools already known to the patient are used to effectively guide them through the rehabilitation process – and at the same time refine and train the algorithm for pre-op patient selection, risk prediction and phenotyping. Check-ins with surgical and orthopedic staff feed the algorithm with data on complications and re-admissions through a link with the Electronic Health Record. Patients report individual satisfaction, experience (PREMs) and outcomes (PROMs) as well as pain scores themselves in the ForPatientApp. The BPMpathway sensor collects Range of Motion (ROM) and corresponding pain levels and simultaneously monitors rehabilitation. Analogous to the pre-OP phase, the Smart Gait Lab (SGL) identifies kinematic and laxity parameters. This width and depth of collected patient data creates a holistic view of the patient’s condition and enables a highly individualized yet efficient medical care in the rehabilitation process.
Improving the future of TKA
Along the entire treatment path individual data from each patient is generated and collected. These deliver new insights and learnings in order to improve clinical results, increase patient satisfaction and to detect time and resource consuming inefficiencies. This way the whole field of TKA can be revolutionized and B. Braun takes on this enormous challenge.
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