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New knee implant under review: will it hold up?

NCT ID NCT07391592

Disease control Sponsor: MicroPort Orthopedics Inc. 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 100 people who received a new type of knee replacement device called EVOLUTION® NitrX™. The goal is to see how safe and effective it is over time. Participants have conditions like arthritis or knee damage. The main measure is a patient-reported score of knee function and pain.

What this could mean

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

Active substance
EVOLUTION® NitrX™ knee replacement device
What this could lead to
If successful, this could confirm that the new knee implant is safe and works well for people needing knee replacement.
What could go wrong
This is a small, post-market study with only 100 participants, so results may not apply to everyone. The device is already on the market, so this is more about confirming safety than discovering a breakthrough.

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

100 people

The number who actually took part.

Started

Aug 2025

Expected to finish

Dec 2032

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

Single study group with either newly or previously implanted patients with all Evolution® NitrX components: Non-Porous Keeled Tibia, CS/CR Non-Porous Femur component, and Evolution® MP CS Tibial insert.

Ages

21 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: * Subjects \> 18 years of age at the time of surgery * Subjects who were implanted with the Evolution® NitrX (SKU # listed below) in MicroPort Orthopedics' intended patient population listed within the Instructions for Use (IFU). * Willing and able to participate in clinical study Exclusion Criteria: * Subjects without follow-up history * Subjects not meeting the inclusion criteria * Contraindications as listed in the IFU * Currently enrolled in another study that could affect the endpoints of this protocol.

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Conditions

The condition(s) this trial relates to.

arthritic joint disease arthropathy avascular necrosis osteoarthritis osteoarthritis susceptibility 6 osteoarthritis, knee osteonecrosis rheumatoid arthritis

As listed by the trial registrant

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

Arthritis knee Avascular necrosis Joint diseases Osteoarthitis Rheumatoid arthritis of knee

Contacts and locations

Locations

  • Sah Orthopaedic Associates

    Fremont, California, 94538, United States

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