Sola2 AMF Knee System for Knee Prosthetic Joint Infection
(AMPLIFY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Adolph V. Lombardi, MD
Principal Investigator
Mount Carmel New Albany Surgical Hospital (JIS Orthopedics)
Peter K Sculco, MD
Principal Investigator
Hospital of Special Surgery (New York)
Are You a Good Fit for This Trial?
This trial is for adults aged 22 or older with a recent (within 45 days) knee implant infection, whose knee prosthesis is working well and listed on the approved device list. Participants must be able to follow instructions, attend follow-up visits, and agree to surgery plus antibiotics.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Debridement, Antibiotics, Implant Retention (DAIR)
- Sola2 AMF Knee System
Trial Overview
The study tests if adding the Sola2 AMF Knee System—a device using alternating magnetic fields—to standard surgery and antibiotics helps improve recovery from knee implant infections. Some participants get the real treatment; others receive a sham (inactive) version for comparison.
How Is the Trial Designed?
5
Treatment groups
Experimental Treatment
Placebo Group
Participants randomized to the active treatment arm receive active Sola2 AMF treatment in conjunction with DAIR and pathogen-appropriate antibiotic therapy. Participants receive two active AMF treatments in the operating room, one before DAIR and one after DAIR and wound closure/bandaging.
Participants in the third open-label sentinel group receive active Sola2 AMF treatment at the planned 65°C AMF temperature level. Participants receive two active AMF treatments in the operating room, one before DAIR and one after DAIR and wound closure/bandaging. Enrollment in this group occurs only after safety review supports progression from Sentinel Group B.
Participants in the second open-label sentinel group receive active Sola2 AMF treatment at the planned 60°C AMF temperature level. Participants receive two active AMF treatments in the operating room, one before DAIR and one after DAIR and wound closure/bandaging. Enrollment in this group occurs only after safety review supports progression from Sentinel Group A.
Participants in the first open-label sentinel group receive active Sola2 AMF treatment at the planned 55°C AMF temperature level. Participants receive two active AMF treatments in the operating room, one before DAIR and one after DAIR and wound closure/bandaging. Safety data are reviewed before progression to the next sentinel group.
Participants randomized to the sham treatment arm receive sham AMF treatment in conjunction with DAIR and pathogen-appropriate antibiotic therapy. Participants undergo the same treatment timing and device-use steps as the active treatment arm, but active AMF energy is not delivered.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Solenic Medical, Inc.
Lead Sponsor
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