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New GPS for knee surgery aims for perfect alignment

NCT ID NCT06955481

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 study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new computer navigation system (OrthoPilot with pheno4u software) to help surgeons perform knee replacements more accurately. About 120 people who need a total knee replacement will take part. The goal is to see if the new software improves how well the implant is positioned and how satisfied patients feel 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
OrthoPilot navigation software for knee replacement surgery
What this could lead to
If successful, this could make knee replacement surgery more precise, potentially leading to better long-term function and fewer complications.
What could go wrong
This is an early-stage study with only 120 participants, so results may not apply to everyone. The new software may not improve outcomes over existing methods.

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 120 people

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

Started

Oct 2025

Expected to finish

Jun 2028

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 between 18 and 80 years of age having indication for a fixed-bearing total knee endoprosthesis, without retropatellar arthrosis requiring patella resurfacing

Ages

18 to 80 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: * Indication for a TKA with the OrthoPilot® Navigation System with a Aesculap total knee endo-prosthesis * Written signed informed consent of patient * Willingness and mental ability to participate at the long-term follow-up examinations Exclusion Criteria: * Pregnancy * Patients \< 18 years or \> 80 years * Patients unable to participate at the follow-up examination (physically, mentally) * Previous joint replacement at the index knee * ASA classification \> 3 ( ASA I: A healthy patient without systemic diseases. ASA II: A patient with a mild systemic disease that is well controlled (e.g., well-controlled diabetes or hypertension). ASA III: A patient with a severe systemic disease that causes functional limitations (e.g., poorly controlled diabetes, COPD). ASA IV: A patient with a life-threatening systemic disease (e.g., severe heart failure, sepsis). ASA V: A dying patient who is not expected to survive without the operation. ASA VI: A deceased patient whose organs are being removed for donation.)

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Conditions

The condition(s) this trial relates to.

arthropathy osteoarthritis osteoarthritis susceptibility 6 osteoarthritis, knee rheumatoid arthritis

As listed by the trial registrant

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

Joint diseases Osteoarthritis, knee Posttraumatic arthropathy Rheumatoid arthritis of knee

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 places running it

    4 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Klinikum Konstanz GmbH

    NOT_YET_RECRUITING

    Konstanz, Baden-Wurttemberg, 78464, Germany

  • Park-Klinik Weißensee

    RECRUITING

    Berlin, 13086, Germany

  • Universitätsklinikum Carl Gustav Carus

    NOT_YET_RECRUITING

    Dresden, 01307, Germany

  • Šumperk Hospital Inc.

    NOT_YET_RECRUITING

    Šumperk, 78701, Czechia

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Other studies related to the condition(s) this trial covers.