New knee implant under review: will it help patients walk without pain?
NCT ID NCT05876143
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is following 400 people who received a U-Knee or Uni-Kroma partial knee implant to see how well it works over time. The goal is to measure how long the implant lasts and whether it improves pain and mobility. Researchers will check results at 1-2 years, 3 years, 5 years, and 10 years after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- unicondylar knee prosthesis (U-Knee / Uni-Kroma implant)
- What this could lead to
- If successful, this could confirm that the U-Knee/Uni-Kroma implant is a safe and effective option for people needing partial knee replacement, reducing pain and restoring mobility.
- What could go wrong
- This is an observational follow-up study, not a randomized trial, so results may be less definitive. Some patients may not experience improvement or could have complications like implant wear or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Jan 2035
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Male or female adult for whom a unicondylar knee prosthesis is indicated according to U-Knee / Uni-Kroma instructions for use. Patients will be followed according to current practice
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: \- All patients using a U-Knee / Uni-Kroma unicompartmental knee prosthesis and benefiting from the social security affiliation scheme. Exclusion Criteria: * Patients who objected to participating in the study and the processing of their data * Patients unable to understand the surgeon's instructions to complete their questionnaires or perform postoperative follow-up * Patients who already have a unicompartmental prosthesis on the knee in question that need to be revised.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Lyon Sud
RECRUITINGPierre-Bénite, France
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