An observational study in Degenerative Osteoarthritis, Rheumatoid Arthritis and Posttraumatic Arthropathy, sponsored by Aesculap AG. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Aesculap AG (part of B. Braun) · Observational
Prospective, multinational pilot study for evaluation of the Pheno4U data platform in Total Knee Arthroplasty (TKA) patients
The study will collect data for each patient receiving an Aesculap Total Knee Arthroplasty (TKA) implant. The data set will be analyzed for critical risk factors among implant and patient data in order to optimize patient-centered therapies.
The products under investigation will be used in routine clinical practice and according to the Instructions for Use (IFU). Data obtained in routine clinical use will be collected in the Pheno4U data platform. In addition, patients are expected to answer questionnaires about their health status. Furthermore, patients are asked to use the so called "BPMpathway" sensor and application in order to measure the active Range of Motion (ROM). The sensor can also be used for pre- and postoperative training .
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 600 is above the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Compared within Arthritis, Rheumatoid, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Joint Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Pheno4U
Total 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
Also known as: Total Knee Arthroplasty
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
Time frame: up to 12 months postoperatively
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.
Time frame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery
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.
Time frame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery
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)).
Time frame: 2 weeks prior to surgery, 6 weeks postoperatively and approximately 1 year after surgery
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".
Time frame: approximately 9 months after surgery
Net Promoter Score
The Net Promoter Score (NPS) is an index ranging from -100 to 100 that measures the willingness of patients to recommend the treatment to others. It is used as a proxy for gauging the patient's overall satisfaction with a treatment. Patients are surveyed on one single question. They are asked to rate on an 11-point scale the likelihood of recommending the treatment to a friend or colleague. "On a scale of 0 to 10, how likely are you to recommend the same treatment to a friend or a colleague?" Based on their rating, customers are then classified in 3 categories: detractors, passives and promoters. 'Detractors' gave a score lower or equal to 6. 'Passives' gave a score of 7 or 8. 'Promoters' answered 9 or 10. The NPS is determined by subtracting the percentage of customers who are detractors from the percentage who are promoters.
Time frame: approximately 12 months after surgery
Change of Depression, Anxiety and Stress Scale - 21 Items
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items with a four point rating scale (ranging 0 - 3 points) for each item. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational anxiety, and subjective experience of anxious affect. The stress scale assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable / over-reactive and impatient. The total score is calculated by summing the scores for the relevant items, the minimum score is 0 points, the maximum score for each section is 21. A lower score represents less depression, anxiety and stress.
Time frame: 1 week prior to surgery and 2 weeks postoperatively
Development of Active Range of Motion
The active Range of Motion (ROM) is measured with the BPMpathway sensor and application 3 times per day for the entire duration of usage of the sensor. In general, the sensor is used for pre- and postoperative training. Patients are expected to use the sensor from pre-op consultation up to 3 month after surgery.
Time frame: up to 3 months after surgery
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.
Time frame: for each x-ray taken in clinical routine up to last follow-up approximately 12 months postoperatively
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.
Time frame: up to last follow-up approximately 12 months postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Jun 2027, 57 months after the start.
Of 155 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 116. This study's planned 57 months is close to that.
Counting every sponsor, half of 389 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
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