Recruiting

Robotic-assisted versus custom-made knee replacement surgery

Plain-English translation of NCT06280352 on ClinicalTrials.gov ↗ · Source last updated January 2025 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This study compares two advanced approaches to total knee replacement surgery for people with severe knee arthritis. You would receive either a custom-made knee implant designed specifically for your anatomy, or a robotic-assisted knee replacement using a standard implant guided by a surgical robot. Researchers will track your recovery, pain relief, satisfaction, and how well each approach works over 2 years.

Both robotic-assisted surgery and custom-made implants are newer technologies that promise better outcomes for knee replacement patients, but doctors don't yet know which approach is truly superior. This trial aims to answer that question so patients and surgeons can make the best choice.

Do you qualify?

You likely qualify if…

you are between 40 and 90 years old
you have been diagnosed with primary osteoarthritis of the knee and need your first total knee replacement
your knee ligaments are intact and stable enough for a standard knee replacement design
you are able to undergo a CT scan of your knee
you speak German and can participate in follow-up visits and evaluations for 2 years
you are willing to sign an informed consent form

You likely don't qualify if…

you have had previous knee surgery, fusion, or bone-cutting procedures on the affected knee
you have severe obesity with a BMI greater than 41
you have significant knee deformity that would require special implant additions or supports
you have a neurological or nerve condition that would prevent you from reporting how the implant feels and works
you are pregnant

What participation looks like

If you qualify, you will be randomly assigned to receive either a custom-made knee implant or a robotic-assisted knee replacement with a standard implant. You'll have surgery at the participating hospital, and then attend follow-up visits at set intervals over 2 years to allow doctors to assess your pain, function, satisfaction, and how well your new knee is working. These visits will include clinical exams and imaging scans.

AI-generated summary from trial data · Jun 3, 2026 · Not medical advice

Trial locations(2 sites)

Austria

AUVA UKH Steiermark Standort Graz, Graz, Styria

AUVA UKH Steiermark Standort Kalwang, Kalwang, Styria