Acute Management of PJI With Local Implant Retention and Antibiotics Using the Sola2 AMF Knee System: A Multicenter Double-blind Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 165
- 主要终点
- Change From Baseline in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
研究概览
简要总结
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:
- Whether adding the Sola2 AMF Knee System improves knee function and quality of life at 6 months.
- Whether adding the Sola2 AMF Knee System to surgery and antibiotic treatment affects the need for additional infection-related surgery.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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) ≥
- •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.
研究组 & 干预措施
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.
干预措施: Intervention 1: Alternating Magnetic Field Treatment (Device)
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.
干预措施: Debridement, Antibiotics, Implant Retention (Procedure)
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.
干预措施: Intervention 1: Alternating Magnetic Field Treatment (Device)
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.
干预措施: Debridement, Antibiotics, Implant Retention (Procedure)
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.
干预措施: Intervention 1: Alternating Magnetic Field Treatment (Device)
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.
干预措施: Debridement, Antibiotics, Implant Retention (Procedure)
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.
干预措施: Intervention 1: Alternating Magnetic Field Treatment (Device)
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.
干预措施: Debridement, Antibiotics, Implant Retention (Procedure)
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.
干预措施: Intervention 2 - Sham Treatment (Device)
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.
干预措施: Debridement, Antibiotics, Implant Retention (Procedure)
结局指标
主要结局
Change From Baseline in Knee Injury and Osteoarthritis Outcome Score for Joint Replacement
时间窗: Baseline to 6 months
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.
Incidence of Infection-Related Surgical Reintervention
时间窗: 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
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.
Incidence of AMF Study Device-Related Adverse Events
时间窗: Through 12 months post-procedure
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.
次要结局
- 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(Through 12 months post-procedure)
- Proportion of Participants With Resolution or Marked Improvement of Infection-Related Symptoms(Through 12 months post-procedure)
- Change From Baseline in Numeric Rating Scale Pain Score(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(Baseline through 12 months post-procedure)
- Change From Baseline in Patient-Reported Outcomes Measurement Information System Patient-Reported Health Status(Baseline through 12 months post-procedure)
- Change From Baseline and Time to Normalization of C-Reactive Protein(Baseline through 12 months post-procedure)
- Change From Baseline and Time to Normalization of Erythrocyte Sedimentation Rate(Baseline through 12 months post-procedure)
- Proportion of Participants Achieving Biomarker Normalization(Through 12 months post-procedure)