Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
Public ClinicalTrials.gov record NCT07700927. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Acute Management of PJI With Local Implant Retention and Antibiotics Using the Sola2 AMF Knee System: A Multicenter Double-blind Clinical Trial.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07700927
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 165 participants
Conditions and interventions
Conditions
Interventions
- Intervention 1: Alternating Magnetic Field Treatment Device
- Intervention 2 - Sham Treatment Device
- Debridement, Antibiotics, Implant Retention Procedure
Device · Procedure
Eligibility (public fields only)
- Age range
- 22 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 30, 2026 (Estimated)
- Primary completion
- Aug 2028 (Estimated)
- Completion
- Aug 2029 (Estimated)
- Last update posted
- Oct 30, 2026
2026 – 2029
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mount Carmel New Albany Surgical Hospital (JIS Orthopedics) | New Albany | Ohio | 43054 | Recruiting |
| Oklahoma Surgical Hospital | Tulsa | Oklahoma | 74137 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07700927, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 30, 2026 · Synced Oct 30, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07700927 live on ClinicalTrials.gov.