Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty

Conditions
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Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy

Intervention / Treatment
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* Device: Navigated total knee arthroplasty
* Device: Robot assisted total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indication for a TKA with a fixed-bearing total knee endoprosthesis Written informed consent for participating in the clinical study Exclusion Criteria: Patient age <18 years and >90 years Patient not willing to participate at the follow-up Pregnancy retropatellar arthrosis requiring patella resurfacing American Society of Anaesthesiologists (ASA) Classification >3

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| OrthoPilot® Elite<br>navigated / computer assisted total knee replacement surgery | Device: Navigated total knee arthroplasty<br>* Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system<br>* Other names: Columbus® total knee endoprosthesis;|
| MAKO<br>robot assisted total knee replacement surgery | Device: Robot assisted total knee arthroplasty<br>* Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system<br>* Other names: Triathlon® total knee endoprosthesis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | one year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | one year postoperatively | 
| Comparison of Radiographic alignment | Alignment (femoral-knee baseline angle, tibial-knee baseline angle, femoral-tibial angle (mechanical)) | 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 | 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. | During the course of the study up to one year postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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computer assisted orthopedic surgery, robotic assisted orthopedic surgery, orthopedic navigation, total knee arthroplasty, total knee replacement