Recruiting

Sola2 AMF

Sponsor:

Solenic Medical, Inc.

Code:

NCT07700927

Conditions

Prosthetic Joint Infection of Knee

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Intervention 1: Alternating Magnetic Field Treatment

Intervention 2 - Sham Treatment

Debridement, Antibiotics, Implant Retention

Study Details

Brief 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

Study ID

NCT07700927

Start date

Oct 30, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2029

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1: Stage 1 Sentinel Group A: Active Sola 2 AMF Treatment 55C

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.

experimental: Arm 2: Stage 1 Sentinel Group B: Active Sola 2 AMF Treatment 60°C

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.

experimental: Arm 3: Stage 1 Sentinel Group C: Active Sola 2 AMF Treatment 65°C

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.

experimental: Arm 4: Stage 2 Randomized Active AMF Treatment

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.

sham comparator: Arm 5: Stage 2 Randomized Sham AMF Treatment

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.

Interventions

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.

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

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.

Primary outcome measure

  • Change From Baseline in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement [ Time Frame: Baseline to 6 months ]
  • Incidence of Infection-Related Surgical Reintervention [ Time Frame: From the index DAIR procedure through the primary efficacy analysis, triggered when 24 adjudicated events have occurred and at least 100 participants have completed 12-month follow-up ]
  • Incidence of AMF Study Device-Related Adverse Events [ Time Frame: Through 12 months post-procedure ]

Central Contacts and Locations

Central contacts

Vice President Clinical Operations

U.S.: 877-765-2612denise.stamos@solenic.com

Chief Medical Officer

U.S.: 877-765-3612david.greenberg@solenic.com

Locations

Mount Carmel New Albany Surgical Hospital (JIS Orthopedics)

Recruiting

New Albany, Ohio, United States, 43054

Contacts

Michael Sneller, Clinical Research Coordinator

614-964-0348SnellerMA@jisortho.com

Principal Investigator:

Adolph Lombardi, MD

Oklahoma Surgical Hospital

Recruiting

Tulsa, Oklahoma, United States, 74137

Contacts

Sandy Black, RN CCRC

918-494-2665sblack@oksurg.com

Principal Investigator:

Sarat Kunapali, MD

More Information

Sponsor

Solenic Medical, Inc.

Last update posted

Oct 30, 2026

Last verified

Oct, 2026

Keywords

  • Periprosthetic joint infection
  • Prosthetic joint infection
  • Knee implant infection
  • Debridement antibiotics and implant retention
  • Biofilm
  • Thermal treatment
  • Alternating Magnetic Field

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-31. This information was provided to ClinicalTrials.gov by Solenic Medical, Inc. on 2026-10-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.