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Surgeons test augmented reality to Fine-Tune knee replacement cuts

NCT ID NCT06663384

Symptom relief Sponsor: Foundation for Orthopaedic Research and Education Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are testing whether an augmented reality guidance system helps surgeons make more accurate bone cuts and align knee implants during total knee replacement. The study enrolls about 50 adults with advanced osteoarthritis who are scheduled for a primary knee replacement using kinematic alignment. Participants receive surgery with either the augmented reality system or conventional jig tools, and researchers compare X-ray measurements of implant alignment plus patient surveys about pain and knee function.

What this could mean

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

Active substance
augmented reality surgical guidance system (ARVIS)
What this could lead to
If it works, augmented reality guidance could help surgeons place knee implants more accurately, which may improve how the knee feels and functions after surgery.
What could go wrong
This is a small pilot study of 50 people, so it can only hint at whether augmented reality beats standard tools. Accuracy on X-rays does not always translate into better pain relief or function for patients.

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 50 people

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

Started

Dec 2024

Expected to finish

Nov 2027

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

18 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: * Age over 18 years old * Scheduled for primary conventional TKA with kinematic alignment * Primary Diagnosis of Osteoarthritis (Killgren Lawrence Grade \> III) on affected side * Able to provide informed consent Exclusion Criteria: 1. Patients with a previous operation of the same knee, including ACL reconstruction, fracture fixation, previous arthroplasty. 2. Patients that had a conversion to a different procedure intraoperatively or shortly after the TKA. 3. Diagnosed with greater than Killgren Lawrence Grade II OA on the contralateral knee 4. Patients that did not complete the TKA. 5. Patients the Investigator deems not able to follow through with study requirements such as follow-up visits or PROM's.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee

As listed by the trial registrant

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

Osteoarthritis

How to take part

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  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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Florida Orthopaedic Institute

    RECRUITING

    Tampa, Florida, 33607, United States

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