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Smart sensors aim to make knee replacements feel more natural

NCT ID NCT06321042

Symptom relief Sponsor: Istituto Ortopedico Rizzoli 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether using a special sensor device during knee replacement surgery leads to better results for patients. The device helps the surgeon make precise bone cuts. Researchers will follow 40 people for up to 2 years after surgery, measuring pain, function, and how much they 'forget' about their new knee.

What this could mean

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

Active substance
Knee replacement surgery using an inertial sensor alignment device
What this could lead to
If successful, this could show that using inertial sensors during knee replacement leads to better pain relief, function, and a more natural-feeling joint.
What could go wrong
This is a small, early study with only 40 people, so results may not apply to everyone. The sensors are a tool, not a new drug, so the improvement 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.

Participants

About 40 people

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

Started

Jan 2023

Expected to finish

Mar 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.

Who is studied

Patients candidates to TKA surgery

Ages

50 to 85 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: 1. Male and female subjects 50 years of age or older and less than 85 years of age (\>50 and \<85 years) who are candidates for primary cemented total knee replacement based on physical examination and medical history, including diagnosis of severe knee pain and disability due to at least one of the following causes: * to. Primary or secondary osteoarthritis * b. Collagen disorders and/or avascular necrosis of femoral condyle * c. Moderate valgus, varus or flexion deformities (HKA between ± 10°, flexion contracture \<10°) - 2. Patients consent and able to complete scheduled study procedures and follow-up assessments. 3. Patients informed about the nature of the study who signed the "informed consent" approved by the ethics committee. Exclusion Criteria: * Simultaneous participation in other studies * Patients not capable of understanding and wanting and therefore unable to sign the informed consent * Patients who have already undergone hip or ankle arthroplasty, previous osteotomy, with severe axial deformities or suffering from rheumatoid arthritis, diabetes or neuromuscular diseases.

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Conditions

The condition(s) this trial relates to.

osteoarthritis osteoarthritis, knee Prosthesis Failure

As listed by the trial registrant

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

Prosthesis durability

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

  • Stefano Zaffagnini

    RECRUITING

    Bologna, Italia, Italy

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