Osteoarthritis, KneeORMAKNCT05980442
Comparative Study of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
An observational study of Osteoarthritis, Knee and Joint Diseases, run by Aesculap AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee
- What is being tested?
- Navigated total knee arthroplasty and Robot assisted total knee arthroplasty
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jul 2024to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Indication for a TKA with a fixed-bearing total knee endoprosthesis
- Written informed consent for participating in the clinical study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Bundeswehr Krankenhaus Ulm
Ulm, Baden-Wurttemberg, 89081
Hans-Joachim Riesner, PD Dr. med.
Jörg Schneider, Dr. med.
About this study
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
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.
- Conditions
- Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
- Being tested
- Navigated total knee arthroplasty, Robot assisted total knee arthroplasty
- Keywords
- computer assisted orthopedic surgery, robotic assisted orthopedic surgery, orthopedic navigation, total knee arthroplasty, total knee replacement
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigated total knee arthroplastyDevice
Also called Columbus® total knee endoprosthesis
Total knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system
Robot assisted total knee arthroplastyDevice
Also called Triathlon® total knee endoprosthesis
Total knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system
| Study group | Role | What they receive |
|---|---|---|
| OrthoPilot® Elite | navigated / computer assisted total knee replacement surgery Receives: Device: Navigated total knee arthroplasty | |
| MAKO | robot assisted total knee replacement surgery Receives: Device: Robot assisted total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year postoperatively
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: one year postoperatively
Comparison of Radiographic alignment
Alignment (femoral-knee baseline angle, tibial-knee baseline angle, femoral-tibial angle (mechanical))
Measured: 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
Measured: 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.
Measured: During the course of the study up to one year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start3 Jul 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hans-Joachim Riesner, PD Dr. med., Principal investigator, Bundeswehr Krankenhaus Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05980442
- Sponsor's protocol ID
- AAG-O-H-23032
- Acronym
- ORMAK
- Status last verified
- Mar 2026
- First submitted
- 19 Jul 2023
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05980442
- Acronym / sponsor ID
- ORMAK / AAG-O-H-23032
- Conditions
- Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy
- Keywords
- computer assisted orthopedic surgery, robotic assisted orthopedic surgery, orthopedic navigation, total knee arthroplasty, total knee replacement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OrthoPilot® Elite | – | Device: Navigated total knee arthroplastynavigated / computer assisted total knee replacement surgery |
| MAKO | – | Device: Robot assisted total knee arthroplastyrobot assisted total knee replacement surgery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Indication for a TKA with a fixed-bearing total knee endoprosthesis
- Written informed consent for participating in the clinical study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigated total knee arthroplastyAlso: Columbus® total knee endoprosthesisTotal knee arthroplasty with Columbus® total knee endoprosthesis using the OrthoPilot® Elite navigation system | Device | OrthoPilot® Elite |
| Robot assisted total knee arthroplastyAlso: Triathlon® total knee endoprosthesisTotal knee arthroplasty with Triathlon® total knee endoprosthesis using the MAKO® robot system | Device | MAKO |
Primary outcome
Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component)
Time frame: 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.
7 secondary outcomes
Survival of the implant components
Time frame: one year postoperatively
Clinical outcome of the Knee Surgery measured by the Knee Society Score (KSS) (clinical component)
Time frame: one year postoperatively
Quality of Life [EQ-5D-5L]
Time frame: one year postoperatively
Anterior knee pain
Time frame: one year postoperatively
Comparison of Radiographic alignment
Time frame: one year postoperatively
Comparison of Radiographic status
Time frame: one year postoperatively
(Serious) Adverse Events
Time frame: During the course of the study up to one year postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hans-Joachim Riesner, PD Dr. med. principal investigator
Bundeswehr Krankenhaus Ulm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Joint Diseases, run by Aesculap AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Maier, Dr. (+49746195, info@aesculap.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome of the Knee Surgery measured by the Knee Society Score (KSS) (functional component) (time frame: one year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.