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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Joint Diseases; Osteoarthritis, Knee; Rheumatoid Arthritis of Knee; Posttraumatic Arthropathy
• Intervention / Treatment: Device: Navigated total knee arthroplasty; Device: Robot assisted total knee arthroplasty

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Kristin Maier, Dr.; Phone Number: +49746195; Email: info@aesculap.de
• Study Contact Backup: Name: Marius Selig; Phone Number: +49746195; Email: info@aesculap.de

Study Locations

• Germany
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89081
      • Bundeswehr Krankenhaus Ulm
      • Contact: Hans-Joachim Riesner, PD Dr. med.
      • Contact: Jörg Schneider, Dr. med.
      • Principal Investigator: Hans-Joachim Riesner, PD Dr. med.
      • Sub-Investigator: Jörg Schneider, Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients between 18 and 90 years of age having indication for a fixed-bearing total knee endoprosthesis, without retropatellar arthrosis requiring patella resurfacing

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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: Columbus® total knee endoprosthesis
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: Triathlon® total knee endoprosthesis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Hans-Joachim Riesner, PD Dr. med., Bundeswehr Krankenhaus Ulm

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 19, 2023
• First Submitted That Met QC Criteria: July 28, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: total knee replacement; total knee arthroplasty; computer assisted orthopedic surgery; robotic assisted orthopedic surgery; orthopedic navigation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
• Other Study ID Numbers: AAG-O-H-23032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No