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New knee implant under Real-World scrutiny: will it deliver better outcomes?

NCT ID NCT07682909

Disease control Sponsor: Aesculap AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study follows about 1,020 people who receive the oneKNEE total knee prosthesis during knee replacement surgery. Researchers track safety and how well the implant works by measuring changes in knee pain and function using the Oxford Knee Score two years after surgery. The goal is to see if this implant provides good clinical outcomes in everyday medical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
oneKNEE total knee prosthesis
What this could lead to
If successful, this could confirm that the oneKNEE implant is safe and effective for improving knee function and reducing pain after total knee replacement.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by patient selection. Complications such as infection, implant loosening, or the need for revision surgery remain possible.

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

About 1,020 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2027

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

Patients receiving a total knee prosthesis

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patient age ≤ 80 years * Indication for a total knee replacement with one of the variants * Written informed consent * Willingness and mental ability to participate at the long-term follow-up examinations Exclusion Criteria: * Contraindications acc. to the Instructions for Use (IFU) * Patient age \< 18 years * Known pregnancy * BMI \> 40 * Secondary gonarthrosis (e.g. rheumatoid arthritis, post-traumatic) * Patients classified as high risk (ASA class \>3) * Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy * Preoperative: aHKA \> 190° or aHKA \< 170° * Preoperative: aHKA \> 190° or aHKA \< 170°\[KB1.1\]\[HO1.2\]\[KB1.3\]\[HO1.4\] * Patients held in a custodial setting und - Patients in a relationship of dependence on the sponsor, the clinic or the investigator

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee periprosthetic joint infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Arthroplasty Arthroplasty, replacement, knee Prosthetic joint infections of knee Tka outcomes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

Study contacts

  • Contact

    Email: •••••@•••••

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    Email: •••••@•••••

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