Comparing two methods for total knee replacement surgery
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
Run by Aesculap AG · NCT05980442 · Data updated 2026-11-12
This study is testing two different knee replacement surgery methods to see if they both help patients recover and feel satisfied with their results.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Status | Recruiting |
| Started | July 3, 2024 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT05980442 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 90 who require total knee arthroplasty due to conditions like osteoarthritis or rheumatoid arthritis.
✕Probably not a fit
Patients with severe comorbidities classified as ASA >3 or those with specific knee conditions requiring additional procedures may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare the safety and performance of two surgical techniques for total knee arthroplasty: navigation-assisted OrthoPilot Elite and robotic-assisted MAKO. It is a randomized, controlled, single-center study that will assess the clinical outcomes and functional results of both approaches. The hypothesis is that both techniques will yield similar results in terms of patient recovery and satisfaction. Participants will be monitored for their progress following the surgery.
Why it matters
Potential benefit: If successful, this study could help determine the most effective surgical method for total knee replacement, potentially improving patient outcomes.
How similar studies have gone: Previous studies comparing robotic-assisted and navigation-assisted techniques have shown promising results, indicating that both methods can be effective, but this specific comparison is less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Bundeswehr Krankenhaus Ulm
Ulm, Baden-Wurttemberg, Germany Recruiting
Study contacts
- Principal investigator: Hans-Joachim Riesner, PD Dr. med. — Bundeswehr Krankenhaus Ulm
- Study coordinator: Kristin Maier, Dr.
- Email: info@aesculap.de
- Phone: +49746195
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.