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

Osteoarthritis, Knee Clinical Trial

— ORMAK  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05980442
• Other study ID #: AAG-O-H-23032
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Aesculap AG
• Contact: Kristin Maier, Dr.
• Phone: +49746195
• Email: info[@]aesculap.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Navigated total knee arthroplasty
Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system
• Robot assisted total knee arthroplasty
Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system

Locations

Country	Name	City	State
Germany	Bundeswehr Krankenhaus Ulm	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Comparison of Radiographic alignment	Alignment (femoral-knee baseline angle, tibial-knee baseline angle, femoral-tibial angle (mechanical))	one year postoperatively
Secondary	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
Secondary	(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