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Robot or Surgeon's hand? trial tests which knee replacement heals faster

NCT ID NCT07716267

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This trial compares robotic-assisted total knee replacement to the conventional manual approach in adults with knee osteoarthritis. All participants follow the same structured home-based rehabilitation program before and after surgery. The study measures knee pain, function, and recovery during the first six weeks to see if robotic assistance offers any advantage.

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 compared with conventional total knee arthroplasty
What this could lead to
If robotic-assisted surgery proves better, it could lead to faster, less painful recovery after knee replacement.
What could go wrong
This is a small, early-stage trial with only 60 participants, so results may not apply to everyone. Both techniques are already in use, and the benefit of robotics may be small.

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 60 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 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.

Ages

40 years and older

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: * Adults aged 40 years or older. * Knee osteoarthritis confirmed by clinical assessment and imaging (e.g., X-ray or MRI) requiring primary total knee replacement surgery. * Scheduled to undergo primary total knee arthroplasty with one of the participating surgeons at St John of God Murdoch Hospital. * Able to understand the study requirements and provide written informed consent. * Physically able to participate in the home-based exercise and stationary cycling rehabilitation program. Exclusion Criteria: * Unable to understand English sufficiently to provide informed consent, complete study questionnaires, or safely follow the rehabilitation program. * Previous major surgery on the leg undergoing knee replacement (for example, revision knee replacement or high tibial osteotomy). * Osteoarthritis caused by another medical condition (for example, inflammatory arthritis, previous joint infection, gout, fracture involving the joint, congenital abnormality, or haemochromatosis). * Chronic pain unrelated to the knee being replaced that could affect study assessments. * Unstable heart or lung conditions that make exercise-based rehabilitation unsafe. * Body weight greater than 120 kg. * Physical conditions that prevent safe participation in the cycling-based rehabilitation program or completion of the study assessments.

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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

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  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

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