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Smart knee implant tracks your steps to speed recovery

NCT ID NCT06089291

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 follows 200 people who received a smart knee implant (Persona IQ) that tracks movement after total knee replacement. The goal is to see if data from the implant and a phone app can help doctors understand recovery and spot problems early. Participants use a smartphone app to share walking data, and researchers compare it to standard recovery measures.

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 200 people

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

Started

Feb 2024

Expected to finish

Dec 2026

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.

Who is studied

The device is indicated for use in patients undergoing a cemented TKA procedure that are normally indicated for at least a 30 mm sized tibial stem extension and/or normally indicated for at least a 58mm sized tibial stem extension. In order to qualify to receive the CTE/CSE with CHIRP system, the patient must meet the following requirements in addition to any requirements for TKA surgery as determined by the patient's surgeon: 1. The Patient's anatomy must be capable of accepting the Zimmer Biomet Persona Tibial Baseplate with CTE/CSE construct sizing. This assessment will be conducted pre-operatively by the surgeon using a CTE/CSE X-ray Template available through your Zimmer Biomet Representative. 2. The patient must have access to a computer with a USB connection to set up their Home Base Station or have access to a compatible smartphone to set up their Home Base Station (Bluetooth). 3. The Patient must have wireless internet in their domicile.

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 * Patient must be 18 years of age or older. * Patient qualifies for primary unilateral, staged bilateral or simultaneous bilateral total knee arthroplasty. * Independent of study participation, patient is a candidate for commercially available Persona IQ Personalized Knee System implanted in accordance with product labeling. * Patient has access to appropriate technology to ensure full functionality for the home base station used as a part of their study procedure. * Patient has access to the mymobility platform via eligible smart device. * Patient must be willing and able to complete the protocol required follow-up. * Patient is willing and able to provide written Informed Consent and Authorization by signing and dating the IRB approved Informed Consent and Authorization form. * Patient is able to read and understand the language used in the mymobility app for their region. Exclusion Criteria * Patient is a current alcohol or drug abuser. * Patient is known to be pregnant, breastfeeding, or considered a member of a protected class (e.g., prisoner, mentally incompetent, etc.). * Patient has a psychiatric illness or cognitive deficit that will not allow proper informed consent and participation in follow-up program. * Patient is currently participating in any other surgical intervention study which would compromise the results of this study, as determined by the Investigator. * Patient has previous history of infection in the affected joint and/or other local/systemic infection that may affect the prosthetic joint. * Patient has Neuropathic Arthropathy. * Patient has osteoporosis, or any loss of musculature or neuromuscular disease that compromises the affected limb, as determined by the Investigator. * Patient has gout, or a history of gout in the affected knee. * Patient is undergoing procedures or treatments using ionizing radiation at or in the proximity of the CTE/CSE. * Off-label use or not according to the approved instructions for use (IFU) of study devices.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Jeffrey Yergler, LLC/South Bend Orthopaedics

    Granger, Indiana, 46530, United States

  • OrthoCarolina Research Institute

    Charlotte, North Carolina, 28207, United States

  • Rothman Institute

    Philadelphia, Pennsylvania, 19107, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.