An observational study in Osteoarthritis, Knee, Joint Diseases and Rheumatoid Arthritis of Knee, sponsored by Aesculap AG. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by Aesculap AG (part of B. Braun) · Observational
The purpose of this PMCF study is to demonstrate the accuracy of navigation using the new pheno4uTKA Level 1 software for OrthoPilot Elite® and to evaluate its safety and performance.
Patient-related outcome measures (PROM) will be acquired to investigate functional outcome and patient satisfaction.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 120 is above the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Aesculap AG is the lead sponsor of 105 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients between 18 and 80 years of age having indication for a fixed-bearing total knee endoprosthesis, without retropatellar arthrosis requiring patella resurfacing
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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Navigation of TKA (Total Knee Arthroplasty) using the new pheno4uTKA Level 1 software for OrthoPilot Elite®.
Procedure: Navigated Total Knee Arthroplasty
The OrthoPilot® Software Pheno4u TKA Level 1 is an application software for computer aided navigation of surgical instruments and serves (in combination with compatible hardware and compatible navigated instruments) as an optional aid for the surgeon during the preparation of the implant site for a compatible knee endoprosthesis.
Comparison of the surgical accuracy between the new OrthoPilot Software and the previous OrthoPilot Software
The primary variable delta (aHKA), is defined as the difference in the arithmetic hip-knee-angle (aHKA) between the 3 months postoperative and the intraoperatively planned value. The aHKA is calculated as the difference of the mechanical medial proximal tibial angle (MPTA) and the mechanical lateral distal femoral angle (LDFA), both measured in degrees.
Time frame: 3 months post OP
Implant survival
Secondary interventions at the index knee
Time frame: ongoing, up to 2 years follow-up
Oxford Knee Score (OKS)
The Oxford Knee Score (OKS) is a validated joint-specific patient-reported outcome measure that is commonly employed to assess the outcome of TKA. It is a 12-item, patient-reported questionnaire originally developed and validated specifically to assess function and pain in patients undergoing TKA. It is short, reproducible, valid and sensitive to clinically important changes over time. OKS ranges from 0 to 48 with 48 being the best outcome.
Time frame: Preoperative,3 months-, 12 months and 2 years post operative
Forgotten Joint Score (FJS)
The FJS-12 contains 12 questions. Every question is scored 1 (never) to 5 (mostly) according to the selected response categories. Thus, the raw score ranges from 12 to 60. The raw score is linearly transformed to a 0-100 scale and then reversed to obtain the final score. Final score = 100 - ((sum(item01 to item12) - 12)/48\*100). Lower scores indicate less awareness of the operated knee during daily activities. The range of the final score is from 0 to 100 (where 0 is worst and 100 means best score)
Time frame: Preoperative,3 months-, 12 months and 2 years post operative
Quality of Life (EQ-5D-5L)
Quality of life of the patients will be analyzed using the 5-dimensions 5-level measure of the EuroQol Group (EQ-5D-5L), which is a simple and generic measure for clinical and economic assessment. The questionnaire covers five different dimensions (mobility, self-care, usual activities,pain/discomfort, anxiety/depression) rated in 5 levels (from "the worst health you can imagine" to "the best health you can imagine"). The questionnaire is filled by the patients themselves.
Time frame: Preoperative, Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months
NET Promotor Score (NPS)
The Net Promoter Score (NPS) was developed for measuring satisfaction in economic research. Colloquially, it is referred to as the "friends and family test". In the healthcare sector, the NPS is used as an overarching measure of patient satisfaction. The NPS metric evaluates the likelihood that a patient will recommend the received healthcare service to others. The NPS is assessed using a scale from 1 to 10. A rating between 9 and 10 is classified as a promoter. A rating between 7 and 8 is considered neutral, and a rating between 0 and 6 is deemed a detractor. The overall score is simply calculated by subtracting the percentage of detractors from the percentage of promoters. Scores range from -100 (everyone is a detractor) to +100 (everyone is a promoter). In the industry, a positive score is viewed favorably, and scores above 50 are considered indicative of strong performance.
Time frame: Postoperative 3 Months + /- 6 weeks, Postoperative 12 months + /- 6 weeks, Postoperative 2 year + /- 3 months
Anterior knee pain
Anterior knee pain will be used to evaluate the performance of the implantation and the implant itself. Rating Description Points: 0 = No pain (0 Points) I = Mild pain that does not intrude on daily activities (5 Points) II= Moderate pain that is a nuisance; patient not considering further surgery (10 Points) III= Severe pain; patient considering further surgery (15 Points)
Time frame: Preoperative,3 months-, 12 months and 2 years post operative
Radiological results
Routinely performed radiographic images are used to evaluate the status of the affected knee, preoperatively, and the status of the implant components, postoperatively. Analysis of parameters will be defined in the radiographic protocol, where precise definition of the implant alignment parameter of the tibial and femoral component by measurement of the LDFA (laterale distale Femurankle) and MPTA (medial proximal Tibiaankle) is given. Both ankles have the same unit and are measured in degrees.
Time frame: Preoperative, Discharge, 1 year post op
All (Serious) Adverse Events
During the course of the study, any upcoming intra- or postoperative (serious) adverse will be documented. The total number of AEs will be summarized and further evaluated by the sponsor and reported according to local legislation and necessity. Recorded complications will be categorized and analyzed to assess the safety of the investigational product.
Time frame: 2 years
Started Oct 2025 (actual). Primary completion is estimated for Jul 2027, 21 months after the start.
Of 220 observational studies under Osteoarthritis, Knee, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 61. This study's planned 21 months is below that.
How these figures are worked out, and which studies are left out of them.
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