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Coated knee implant aims to block metal particles

NCT ID NCT05151315

Symptom relief Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers compare two knee replacement implants in 50 people with knee osteoarthritis. One implant has a NitrX coating meant to stop metal ions from escaping; the other does not. Using special X-rays, blood tests, and MRI scans, the team tracks whether the implants shift over time and whether metal particles trigger inflammation. Participants also answer questions about joint function and satisfaction.

What this could mean

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

Active substance
a knee replacement implant with a NitrX coating designed to block metal ion release, compared with the same implant without the coating
What this could lead to
If the coating works, it could reduce metal-related reactions and implant loosening, helping knee replacements last longer for people with metal sensitivity.
What could go wrong
This is a small study of 50 people, so it may not detect small differences between the implants. The coating might not reduce metal particles or implant movement enough to matter, and any benefit would need confirmation in larger trials.

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

Aug 2022

Expected to finish

Feb 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

21 to 80 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: * Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty * Varus knee deformity of 0 to 10 degrees * Sufficient ligamentous function to warrant retention of the posterior cruciate ligament * Between ages of 21 and 80 inclusive * Patients willing and able to comply with follow-up requirements and self-evaluations * Ability to give informed consent * No contraindications to Magnetic Resonance Imaging (MRI) Exclusion Criteria: * Active or previous infection * Medical condition precluding major surgery * Inflammatory arthropathy * Prior Patellectomy * PCL deficiency * Major Coronal plane deformity * Valgus deformity * Bone defects requiring augments, cones and/or stemmed implants

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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.

Knee osteoarthritis Radiostereometric analysis Total knee arthroplasty

Contacts and locations

Locations

  • London Health Sciences Centre

    London, Ontario, N6A5A5, Canada

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