An observational study in Osteoarthritis, Knee, Joint Diseases and Rheumatoid Arthritis of Knee, sponsored by Aesculap AG. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Aesculap AG (part of B. Braun) · Observational
Randomized, controlled, single center observational study to compare the safety and performance of navigation-assisted OrthoPilot Elite and robotic-assisted MAKO total knee arthroplasty (TKA). The aim of the study is the comparison of the clinical outcome between navigated and robotic-assisted TKA. The hypothesis of the study is that both treatments achieve similar results regarding functional and clinical aspects.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's planned enrollment of 140 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 90 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.
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.
navigated / computer assisted total knee replacement surgery
Device: Navigated total knee arthroplasty
robot assisted total knee replacement surgery
Device: Robot assisted total knee arthroplasty
Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system
Also known as: Columbus® total knee endoprosthesis
Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system
Also known as: Triathlon® total knee endoprosthesis
Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)
Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
Time frame: one year postoperatively
Survival of the implant components
Kaplan-Meier Analysis is a standard statistical method to describe the survival of human subjects or medical products over a defined time period. The revision-free survival rate is the performance indicator of the product under investigation and confirms the clinical outcome of the knee prosthesis. Information on survival of the implant will be collected.
Time frame: one year postoperatively
Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component)
Functional result one year postoperatively measured with the functional component of the Knee Society Score (KSS). The KSS is an examiner-administrated standard clinical evaluation tool reporting results for patients undergoing TKA. It separates findings in the operated knee (kKSS) score from findings related to the patient's function (fKSS), which might be affected by co-morbidities. The two sub-scores are reported separately ranging from 0 points (worst result) to 100 points (best results), as well as summarized score, total KSS. Final grading of total KSS results Scores of 160 to 200 will be rated as excellent, 140 to 159 as good, 120 to 139 as fair, and less than 120 as poor.
Time frame: one year postoperatively
Quality of Life [EQ-5D-5L]
EQ-5D is a standardized 5-dimension (5D) 5-level (5L) measure of the health status and is developed by the EuroQol Group in order to have a simple and generic measure for clinical and economic assessment. Instructions for the user are directly included into the questionnaire and it consists of two pages. One cover five different dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression) and the other one the EQ visual Analogue Scale (EQ-VAS). The VAS scale records the self rated health status of the patient from the level "the worst health you can imagine" to "the best health you can imagine".
Time frame: one year postoperatively
Anterior knee pain
Anterior knee pain is used to evaluate the performance of the implantation and the implant itself. Rating is classified according to the description of Waters and Bentley in four dimensions: 0 (no pain), I (Mild pain that does not intrude on daily activities), II (Moderate pain that is a nuisance; patient not considering further surgery), III (Severe pain; Patient considering further surgery). The scoring is according to Feller et al. 0, 5, 10 and 15 points, respectively.
Time frame: one year postoperatively
Comparison of Radiographic alignment
Alignment (femoral-knee baseline angle, tibial-knee baseline angle, femoral-tibial angle (mechanical))
Time frame: one year postoperatively
Comparison of Radiographic status
potential presence of radiolucency at the interface between implant and bone on femoral and tibial components will be analyzed
Time frame: one year postoperatively
(Serious) Adverse Events
During the course of the study, any upcoming intra- or postoperative (serious) adverse device events or effects ((S)AE) related or not related to the product under investigation, will be documented. The total number of (S)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 in order to assess the safety of the investigational product.
Time frame: During the course of the study up to one year postoperatively
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2024 (actual). Primary completion is estimated for Dec 2027, 41 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 41 months is above that.
How these figures are worked out, and which studies are left out of them.
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