ORMAK: Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| OrthoPilot® Elite navigated / computer assisted total knee replacement surgery |
Device: Navigated total knee arthroplasty
Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system
Other Names:
|
| MAKO robot assisted total knee replacement surgery |
Device: Robot assisted total knee arthroplasty
Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component) [one year postoperatively]
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.
Secondary Outcome Measures
- Survival of the implant components [one year postoperatively]
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.
- Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component) [one year postoperatively]
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.
- Quality of Life [EQ-5D-5L] [one year postoperatively]
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".
- Anterior knee pain [one year postoperatively]
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.
- Comparison of Radiographic alignment [one year postoperatively]
Alignment (femoral-knee baseline angle, tibial-knee baseline angle, femoral-tibial angle (mechanical))
- Comparison of Radiographic status [one year postoperatively]
potential presence of radiolucency at the interface between implant and bone on femoral and tibial components will be analyzed
- (Serious) Adverse Events [During the course of the study up to one year postoperatively]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Indication for a TKA with a fixed-bearing total knee endoprosthesis
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Written informed consent for participating in the clinical study
Exclusion Criteria:
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Patient age <18 years and >90 years
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Patient not willing to participate at the follow-up
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Pregnancy
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retropatellar arthrosis requiring patella resurfacing
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American Society of Anaesthesiologists (ASA) Classification >3
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bundeswehr Krankenhaus Ulm | Ulm | Baden-Württemberg | Germany | 89081 |
Sponsors and Collaborators
- Aesculap AG
Investigators
- Principal Investigator: Hans-Joachim Riesner, PD Dr. med., Bundeswehr Krankenhaus Ulm
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAG-O-H-23032