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Robot-Assisted knee surgery tests custom alignment for Longer-Lasting implants

NCT ID NCT06507046

Disease control Sponsor: Helse Møre og Romsdal HF 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This trial tests two ways of aligning a new knee joint during robotic surgery: the traditional mechanical alignment that keeps the leg straight, and a personalized kinematic alignment that matches the patient's natural anatomy. Researchers will track how well the implant stays in place over time using special CT scans. The goal is to see if a more natural alignment leads to better function and longer-lasting results for people with knee osteoarthritis.

What this could mean

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

Active substance
total knee replacement with either personalized (kinematic) alignment or mechanical alignment
What this could lead to
If personalized alignment works better, it could mean longer-lasting knee implants and better function for people with knee osteoarthritis.
What could go wrong
This is a mid-sized trial, and the benefits of personalized alignment may not be large enough to change standard practice. There are always surgical risks like infection or implant failure.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 152 people

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

Started

Aug 2024

Expected to finish

May 2035

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

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: • femoro-tibial or patello-femoral osteoarthritis (Kellgren-Lawrence, K-L) grade 2-4 with persistent pain, referred to Kristiansund Hospital for primary TKA Exclusion Criteria: * serious psychiatric disorders * dementia * drug abuse * patients not able to speak and read Norwegian language making them noncompliant or unable to perform an informed consent * Patients with ongoing cancer therapy * Patients with ASA (The American Society of Anesthesiologists physical status class risk stratification system) classification \>3 * Patients in the need of walking aid devices * Patients in need of primary revision arthroplasty or more than 15 degrees of varus or 5 degrees of valgus on preoperative HKA images.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

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

Knee osteoarthritis

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  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

Locations

  • Kristiansund Hospital, Møre and Romsdal Hospital Trust

    RECRUITING

    Kristiansund, Møre and Romsdal, 6508, Norway

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