Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
Patient undergoing a total knee arthroplasty with a B. Braun knee implant system
Signed written informed consent
Patient's willingness & ability to use the "BPMpathway"sensor
Patient's willingness & ability to use the "4Patient" application
Patient age < 18 years
Patient not willing to participate at the further follow-up
Pregnancy
If intraoperatively an implant from a different manufacturer is used, the study patient has to be excluded from the study.
Patients will be recruited consecutively. No selection besides the inclusion and exclusion criteria will take place. Four different TKA implant systems can be used within the study: Columbus, E.motion, Enduro and VEGA according to the instructions for use.
Cohort
Prospective
Pheno4U
DeviceTotal Knee Arthroplasty represents a well-established, reliable and successful treatment option for end-stage bicompartmental osteoarthritis or other indications resulting in joint destruction. In general, Implantation of a total knee prosthesis improves the quality of life through pain alleviation, deformity correction, joint stabilization, and/or functional range of motion (ROM) through restoration of normal knee kinematics and functionality
Identification of any unknown risks or side effects in Total Knee Arthroplasty by using sensors and patient apps
The study will collect data for each patient receiving an Aesculap TKA implant. The data set will be analyzed for critical risk factors among implant and patient data in order to optimize patient-centered therapies
Change of Knee Injury and Osteoarthritis Outcome score
The Patient self-assessed Injury and Knee Osteoarthritis Outcome Scores (KOOS) is a joint-specific instrument: The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems.
Change of Hospital for Special Surgery (HSS) Knee Surgery Expectations Survey
The Hospital for Special Surgery (HSS) Knee Surgery Expectations Survey is a 17 item questionnaire. The survey is comprised of five different categories of expectations: pain, walking, psychological state, essential activities and non-essential activities. The responses range from ''very important'' (score: 1) to ''this does not imply to me'' (score: 5). The total summed raw score ranges from 0 to 76 and the transformed score \[ = (raw score/76)×100\] ranges from 0 to 100. Higher scores indicate expecting more improvement for more items.
Change of Pain
Information on pain is collected by the so called "painDETECT" questionnaire, a self-reported screening tool for the identification of neuropathic pain. The questionnaire contains seven weighted sensory descriptors, one item relating to spatial pain characteristics and one item relating to temporal characteristics. A total score ranging from -1 to 38 can be calculated. The total score is divided into three categories (unlikely neuropathic pain (\<13), unclear (13-18), likely neuropathic pain (\>18)).
Patient satisfaction
Based on a single question 9 months after surgery patients are asked to grade their level of satisfaction with the methodology and rehabilitation procedure. They can choose between "very dissatisfied", "dissatisfied", "satisfied" or "very satisfied".
Cumulative Radiological Evaluation
Imaging will be used to evaluate the implant status as well as device condition and potential presence of device-related Adverse Events including fracture, wear, loosening or radiolucencies.
Cumulative Rate of (Serious) Adverse Events
During the course of the study any upcoming intra- or postoperative (serious) adverse events directly or possibly related to the products under investigation will be documented in the dedicated electronic case report forms (eCRFs). Recorded complications will be categorized and analyzed in order to assess the safety of the investigational products.
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