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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:
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:
The AMPLIFY trial is a prospective, multicenter, staged clinical investigation of the investigational Sola2 AMF Knee System in adults with confirmed knee periprosthetic joint infection (PJI) who will undergo debridement, antibiotics, and implant retention (DAIR) surgery and pathogen-appropriate antibiotic therapy.
The study is conducted under a single Investigational Device Exemption and includes two stages. Stage 1 is an open-label sentinel stage using sequential AMF temperature escalation. Sentinel participants receive active Sola2 AMF treatment, with safety review after each sentinel group before progression to the next planned temperature level or to the randomized stage. Stage 2 is a randomized, double-blind, sham-controlled stage in which participants are assigned to active Sola2 AMF treatment or sham AMF treatment.
The Sola2 AMF Knee System is an external, non-contacting investigational device that generates alternating magnetic fields intended to produce controlled heating at metallic knee implant surfaces. The AMF or sham treatment is administered in the operating room in conjunction with the planned DAIR procedure. All participants receive DAIR and pathogen-appropriate antibiotic therapy as part of their clinical care.
Safety oversight includes medical monitoring, independent Data Safety Monitoring Board review, and independent Clinical Events Committee adjudication as specified in the protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Stage 1 Sentinel Group A: Active Sola 2 AMF Treatment 55C | Experimental | 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. |
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| Arm 2: Stage 1 Sentinel Group B: Active Sola 2 AMF Treatment 60°C | Experimental | 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. |
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| Arm 3: Stage 1 Sentinel Group C: Active Sola 2 AMF Treatment 65°C | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention 1: Alternating Magnetic Field Treatment | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement | Change from baseline to 6 months in the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement. The score is reported using the validated 0 to 100 interval scoring method, with higher scores indicating better knee health. | Baseline to 6 months |
| Incidence of Infection-Related Surgical Reintervention | Number and percentage of participants with a qualifying infection-related surgical reintervention event, as adjudicated by an independent Clinical Events Committee. Qualifying events include surgical reintervention due to relapse or surgical reintervention for ongoing infection, as defined in the protocol. Only the first adjudicated qualifying surgical reintervention event per participant contributes to the primary endpoint analysis. | 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 | Number and percentage of participants with one or more adverse events determined to be related to the AMF study device. Potential primary safety endpoint events are independently adjudicated by the Clinical Events Committee according to the CEC charter. | Through 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence, Severity, and Relatedness of Adverse Events and Serious Adverse Events | Between-arm comparison of the incidence, severity, and relatedness of adverse events and serious adverse events. | Through 12 months post-procedure |
| Time to Resolution and Duration of PJI-Related Signs and Symptoms |
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Inclusion Criteria
Eligible participants must meet all of the following criteria:
Exclusion Criteria
Participants meeting any of the following criteria will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vice President Clinical Operations | Contact | U.S.: 877-765-2612 | 711 | denise.stamos@solenic.com |
| Chief Medical Officer | Contact | U.S.: 877-765-3612 | 703 | david.greenberg@solenic.com |
| Name | Affiliation | Role |
|---|---|---|
| Adolph V. Lombardi, MD | Mount Carmel New Albany Surgical Hospital (JIS Orthopedics) | Principal Investigator |
| Peter K Sculco, MD | Hospital of Special Surgery (New York) | Principal Investigator |
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This staged study includes a sequential open-label sentinel stage (Stage 1) followed by a randomized, double-blind, sham-controlled stage (Stage 2). In Stage 1, sentinel participants are enrolled sequentially into planned AMF temperature groups, with independent safety review before progression to the next group and before initiation of Stage 2. In Stage 2, participants are randomized 1:1 to active Sola2 AMF treatment or sham AMF treatment. All participants receive DAIR surgery and pathogen-appropriate antibiotic therapy.
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Stage 1 Sentinel is open-label. In Stage 2, the Sponsor, device operators, and site personnel are also masked to assignment to active Sola2 AMF treatment or sham AMF treatment. Treatment assignment is embedded within the investigational device system and is not accessible to investigators, device operators, or site personnel during the conduct of the trial. The independent Data Safety Monitoring Board may review unmasked safety data as specified in its charter. Treatment assignment information may be made available for limited safety-related assessments, including device-related adverse event relatedness, as specified in the protocol and committee charters. Emergency unblinding may occur only when needed for participant safety or clinical management.
| Arm 4: Stage 2 Randomized Active AMF Treatment |
| Experimental |
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. |
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| Arm 5: Stage 2 Randomized Sham AMF Treatment | Sham Comparator | 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. |
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| Intervention 2 - Sham Treatment | Device | 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 |
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| Debridement, Antibiotics, Implant Retention | Procedure | 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. |
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Between-arm comparison of the time to resolution and duration of PJI-related signs and symptoms, such as pain, drainage, erythema, and edema. |
| Through 12 months post-procedure |
| Proportion of Participants With Resolution or Marked Improvement of Infection-Related Symptoms | Between-arm comparison of the proportion of participants with resolution or marked improvement of infection-related symptoms at scheduled follow-up visits. | Through 12 months post-procedure |
| Change From Baseline in Numeric Rating Scale Pain Score | Between-arm comparison of change from baseline in participant-reported pain using the Numeric Rating Scale at scheduled follow-up visits. Scores range from 0 to 10, with higher scores indicating greater pain. | Baseline through 12 months post-procedure |
| Change From Baseline in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement at Follow-Up Visits Over Time | Between-arm comparison of change from baseline in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement at scheduled follow-up visits other than the 6-month primary endpoint. Scores are reported using the validated 0 to 100 interval scoring method, with higher scores indicating better knee health. | Baseline through 12 months post-procedure |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System Patient-Reported Health Status | Between-arm comparison of change from baseline in Patient-Reported Outcomes Measurement Information System patient-reported health status at scheduled follow-up visits. | Baseline through 12 months post-procedure |
| Change From Baseline and Time to Normalization of C-Reactive Protein | Between-arm comparison of change from baseline and time to normalization of C-reactive protein among participants with elevated C-reactive protein at enrollment. Normalization is defined according to the reference range of the performing laboratory. | Baseline through 12 months post-procedure |
| Change From Baseline and Time to Normalization of Erythrocyte Sedimentation Rate | Between-arm comparison of change from baseline and time to normalization of erythrocyte sedimentation rate among participants with elevated erythrocyte sedimentation rate at enrollment. Normalization is defined according to the reference range of the performing laboratory. | Baseline through 12 months post-procedure |
| Proportion of Participants Achieving Biomarker Normalization | Proportion of Participants Achieving Biomarker Normalization | Through 12 months post-procedure |
| ID | Term |
|---|---|
| D003646 | Debridement |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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