Comparing two methods for total knee replacement surgery
Randomized, Controlled, Single Center Observational Study to Compare the Safety and Performance of Navigation-assisted OrthoPilot® Elite and Robotic-assisted MAKO® Total Knee Arthroplasty
Aesculap AG · NCT05980442
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 |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Aesculap AG (industry) |
| Locations | 1 site (Ulm, Baden-Wurttemberg) |
| Trial ID | NCT05980442 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Ulm, Baden-Wurttemberg
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis, Knee, Joint Diseases, Rheumatoid Arthritis of Knee, Posttraumatic Arthropathy, computer assisted orthopedic surgery, robotic assisted orthopedic surgery, orthopedic navigation, total knee arthroplasty