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Robot vs surgeon: which knee replacement works better?

NCT ID NCT07201207

Disease control Sponsor: Satakunta Central Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares robotic-assisted knee replacement to the traditional manual method in 170 adults aged 50-80 with end-stage knee arthritis. Participants are randomly assigned to one of the two surgeries and followed for 2 years to measure knee function, recovery speed, and cost, with a 10-year check for complications. The goal is to see if robotic guidance leads to better outcomes and fewer problems.

What this could mean

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

Active substance
Robotic-assisted total knee arthroplasty (MAKO) vs manual total knee arthroplasty
What this could lead to
If robotic-assisted knee replacement proves better, it could lead to improved function, faster recovery, and fewer complications for people with severe knee arthritis.
What could go wrong
This is a single-center trial with 170 participants, so results may not apply to everyone. The difference between methods might be small, and robotic surgery is more expensive.

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 170 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Sep 2037

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

50 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 * Age over 50 and below 80 years * End-stage Kellgren-Lawrence grade IV KOA * Failed conservative treatment Exclusion criteria * Post-traumatic knee osteoarthritis * Rheumatoid arthritis * Previous knee infections * Previous knee surgery (other than diagnostic arthroscopy or meniscectomy) * Knee range of motion within 15 to 100 degrees * Mechanical axis over 15 degrees of varus or over 10 degrees of valgus * Body mass index over 40 kg/m2 * Significant patellofemoral osteoarthritis (Kellgren-Lawrence grade III or IV) * Diabetes treated with insulin * Malignancy with ongoing treatment * Systemic glukocorticosteroid or antimetabolite medication during the last 5 years * Conditions that do not allow general anesthesia * Patients' denial for operative treatment and/or participation in the trial

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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.

Osteoarthritis, knee

How to take part

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

  1. 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 ↗

  2. 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.

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