A Phase 2 Multicenter Feasibility Trial to Evaluate Safety and Efficacy in Patients Treated for Hip or Knee Prosthetic Joint Infection (PJI) With Alternating Irrigation of Vancomycin Hydrochloride (HCl) and Tobramycin Sulfate in Two-Stage Exchange Arthroplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Safety Evaluations: Number and Frequency of Adverse Events Among Participants
研究概览
简要总结
Study Type
Prospective, single-arm, open-label, multicenter (3 to 5 sites), interventional trial.
Primary Study Objective
The objective of the study is to determine the safety profile of local antibiotic irrigation for the treatment of PJI.
Primary Outcome Measure
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
Follow-up
Patients will be assessed for all measures at 3 weeks, 6 weeks, 12 weeks, and 12 months from initial surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years or greater
- •Preoperative diagnosis of PJI of the hip or knee per the 2018 Definition of Periprosthetic Hip and Knee Infection
- •Chronic PJI (symptoms lasting at least 4 weeks) per Tsukayama et al.
- •Medical clearance for surgery
- •Physical and mental ability and willingness to comply with the protocol, including the ability to read and complete required forms, and willingness and ability to adhere to the scheduled follow-up visits and requirements of the protocol
排除标准
- •Late acute hematogenous infection per Tsukayama et al.
- •Patients for whom a two-stage exchange arthroplasty is not indicated
- •Previously failed single- or two-stage revision arthroplasty for PJI (aseptic revision, polyethylene liner exchange, and/or irrigation and debridement with component retention is allowed)
- •Patients with PJI of more than one joint
- •Patients on chronic antibiotic therapy (≥ 6 months duration)
- •Patients who require therapeutic anticoagulation
- •Patients on antiplatelet therapy for whom withholding antiplatelet therapy for any amount of time is contraindicated
- •Patients with renal insufficiency/failure (serum creatinine ≥ 2.0 mg/dl)
- •Patients with uncontrolled diabetes, defined as: hemoglobin A1C levels > 8.0%
- •Patients on immunosuppressive therapy, chemotherapy for malignant disease, or glucocorticoid therapy (e.g. prednisone ≥ 10 mg/day).
- •Patients with immunodeficiency (e.g., splenectomy; sickle cell anemia; Stage 3 HIV; primary humoral, bone marrow, or other transplantation.)
- •Anticipated or potential patient relocation that may interfere with follow-up examinations
- •Allergy to vancomycin HCl or tobramycin sulfate (Note: prior history of Red Man's syndrome is not considered an allergy)
- •Patients who are pregnant or planning to become pregnant
- •Patients in whom negative pressure wound therapy is contraindicated
- •Patients infected with pathogens that are not considered susceptible to vancomycin HCl or tobramycin sulfate, as per the Investigator's opinion
- •Breastfeeding at screening visit
- •Patients who are prisoners
- •Participation in another clinical trial of another Investigational Drug or Investigational Device within the past 30 days
结局指标
主要结局
Safety Evaluations: Number and Frequency of Adverse Events Among Participants
时间窗: 12 months
The overall safety profile is characterized by assessing the incidence of adverse events (AEs), serious adverse events (SAEs), suspected adverse reactions, adverse reactions, and unexpected adverse reactions.
次要结局
未报告次要终点