Magnetic heat zaps infection in knee implants without removal

NCT ID NCT07700927

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether a device that uses alternating magnetic fields to heat metal knee implants can help treat infections without removing the implant. Adults with a knee implant infection receive surgery, antibiotics, and either active or sham magnetic treatment. The study measures knee function, infection recurrence, and safety over 6 to 12 months.

What this could mean

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

Active substance
Alternating magnetic field treatment delivered by the Sola2 AMF Knee System, an external device that heats metal knee implants to fight infection during surgery.
What this could lead to
If successful, this approach could offer a new way to treat knee implant infections without removing the implant, potentially preserving knee function and reducing the need for additional surgeries.
What could go wrong
This is an early-stage trial with a small number of participants, so results may not apply to everyone. The treatment involves heating implants, which could cause tissue damage or other side effects.

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 165 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Aug 2029

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.

Ages

22 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 Eligible participants must meet all of the following criteria: * Adult male or female participant aged ≥ 22 years at the time of surgery. * PJI diagnosis of "infected" knee per the 2018 MSIS Definition of Periprosthetic Hip and Knee Infection. * Patient presents with PJI symptoms lasting for ≤ 45 days. * Well-fixed and functioning prosthesis during clinical exam at screening. * Patient to be treated with DAIR, polyethylene spacer exchange and pathogen- appropriate antibiotic therapy. * Implanted knee prosthesis must appear on the "AMPLIFY Implant List". * All implanted knee prosthesis components must have a legible device identification label (implant sticker) available in the medical record. * Able to comprehend and comply with postoperative instructions and willing to return for follow-up visits for the duration of the study. * Consent to participate in study and sign the Informed Consent Form (ICF). Exclusion Criteria Participants meeting any of the following criteria will be excluded: * Implanted knee prosthesis not appearing on the "AMPLIFY Implant List". * Implanted knee prosthesis has any femoral and/or tibial augments, sleeves, cones, or modified/extended stems. * Un-resurfaced patella. * Metal-backed patellar components. * Patients not indicated for a DAIR procedure pre-operatively. * Patients undergoing bilateral DAIR procedures during the same surgical session. * Pre-operative determination that the surgical wound cannot be closed primarily and requires a wound vac as a method of wound closure (e.g., open wound managed for secondary intention healing or delayed primary closure); Use of closed-incision negative pressure therapy over a primarily closed incision is permitted. * Previous DAIR procedure(s) performed on the affected knee joint within the last two years. * Patients presenting with PJI symptoms lasting for \>45 days. * Patients on antibiotic therapy for an infection other than PJI of the knee. * Body Mass Index (BMI) ≥ 45. * Patients currently on bone-marrow suppressive chemotherapy for malignancy. * Patients currently with active neutropenia. * Presence of metallic implant(s), other than the femoral and tibial components, within the Sola2 treatment zone (+/- 20 centimeters from the knee joint line) including intramedullary nails, hip prosthesis femoral stem, or fracture fixation hardware. * Patients with an upper-thigh circumference greater than 70 centimeters (cm) (28 inches (in), measured approximately 15 cm (6 in) proximal to the superior pole of the patella. * Patients with implanted or nonremovable cardiac pacemakers, defibrillators or cardioverters, insulin pumps, nerve stimulators, or any other indwelling infusion pump. * Patients who are pregnant or nursing.

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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.

How to take part

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  1. The official record

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  2. A doctor treating you

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