Sola2 AMF Knee System added to surgery and antibiotics for knee implant infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AMPLIFY is a multicenter, staged study evaluating the Sola2 AMF Knee System in adults with knee periprosthetic joint infection undergoing DAIR surgery. Stage 1 uses sequential, escalating AMF temperature levels in an open-label safety phase; safety reviews occur after sentinel groups before proceeding. Stage 2 is a randomized, double-blind, sham-controlled comparison of active AMF treatment versus sham, all in conjunction with DAIR and pathogen-appropriate antibiotics. The device delivers controlled magnetic heating to the implant surface during the surgical procedure, with safety oversight by a Data Safety Monitoring Board and an independent Clinical Events Committee. All participants receive standard care including debridement, antibiotics, and implant retention.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mount Carmel New Albany Surgical Hospital (JIS Orthopedics)
  New Albany, Ohio, United States Recruiting
• Oklahoma Surgical Hospital
  Tulsa, Oklahoma, United States Recruiting

Study contacts

• Principal investigator: Adolph V. Lombardi, MD — Mount Carmel New Albany Surgical Hospital (JIS Orthopedics)
• Study coordinator: Vice President Clinical Operations
• Email: denise.stamos@solenic.com
• Phone: U.S.: 877-765-2612

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.