Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection

Summary

The goal of this clinical trial is to learn whether the Sola2 AMF Knee System, when added to surgery and antibiotic treatment, can safely improve outcomes, knee function, and quality of life in adults with knee implant infection.

The main questions this study aims to answer are:

1. Whether adding the Sola2 AMF Knee System improves knee function and quality of life at 6 months.
2. Whether adding the Sola2 AMF Knee System to surgery and antibiotic treatment affects the need for additional infection-related surgery.
3. Whether the Sola2 AMF Knee System can be used safely, based on device-related adverse events through 12 months.

This study has two stages. In Stage 1, participants will be enrolled into sequential sentinel groups at increasing AMF temperature levels. All sentinel participants will receive active Sola2 AMF treatment. A safety review will occur after each sentinel group before proceeding to the next group. In Stage 2, researchers will compare participants who receive active Sola2 AMF treatment to participants who receive sham AMF treatment. All participants will receive surgery called debridement, antibiotics, and implant retention (DAIR), and antibiotic treatment for knee implant infection.

Participants will:

* Have DAIR surgery for knee implant infection;
* Receive pathogen-appropriate antibiotic treatment from the study doctor;
* If enrolled in Stage 1, receive active Sola2 AMF treatment at the designated sentinel temperature level;
* If enrolled in Stage 2, receive either active Sola2 AMF treatment or sham AMF treatment, depending on randomization assignment; and
* Complete follow-up visits and assessments for safety, infection status, pain, knee function, x-rays, laboratory tests, and other study-related outcomes.

Conditions

• Prosthetic Joint Infection of Knee

Interventions

DEVICE

Intervention 1: Alternating Magnetic Field Treatment

Active alternating magnetic field treatment is delivered using the investigational Sola2 AMF Knee System. The system is an external, non-contacting device that generates alternating magnetic fields intended to produce controlled heating at metallic knee implant surfaces. Treatment is administered in the operating room in conjunction with DAIR.

DEVICE

Intervention 2 - Sham Treatment

Sham alternating magnetic field treatment is delivered during the randomized stage using the Sola2 AMF Knee System workflow. The sham treatment uses the same treatment timing and device-use steps as active treatment, without delivery of active alternating magnetic field energy

PROCEDURE

Debridement, Antibiotics, Implant Retention

Debridement, antibiotics, and implant retention is the planned surgical treatment for participants with knee prosthetic joint infection participants. In this study, all participants undergo DAIR, including polyethylene spacer exchange, and receive pathogen-appropriate antibiotic therapy as part of standard clinical care.

Sponsors & Collaborators

• Solenic Medical, Inc.

  lead INDUSTRY

Principal Investigators

• Adolph V. Lombardi, MD · Mount Carmel New Albany Surgical Hospital (JIS Orthopedics)

• Peter K Sculco, MD · Hospital of Special Surgery (New York)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2028-08-31

Completion

2029-08-31

FDA Device

Yes