Evaluating XPERIENCE™ Advanced Surgical Irrigation on Risk of Periprosthetic Joint Infection: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7,600
- 试验地点
- 19
- 主要终点
- Rate of acute (<90 days post-surgery) PJI
研究概览
简要总结
A prospective, multi-center, double-arm, parallel, interventional, randomized, controlled clinical trial to assess the rate of periprosthetic joint infection (PJI) in patients undergoing primary total knee arthroplasty (TKA), total hip arthroplasty (THA) or hip resurfacing (HR) with XPERIENCE™ (XP) Advanced Surgical Irrigation versus dilute Betadine (DB).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Male and female patients aged 18 years or older
- •Diagnosis of osteoarthritis, inflammatory arthritis, osteonecrosis, or post-traumatic arthritis to the affected joint.
- •Primary TKA, THA, and HR
- •Subjects receiving both cemented or uncemented orthopaedic implants
- •Willing and able to sign written consent, follow study protocol and attend follow-up
排除标准
- •Inability or refusal to sign informed consent form
- •Non-English or French speaking, and no licensed translator, family member or substitute decision maker available.
- •Prior arthroplasty procedure to the affected joint
- •Procedures involving solid HA implants
- •Oncologic diagnosis to the affected joint.
- •Non-TKA, THA or HR prosthesis (i.e., hemiarthroplasty, unicompartmental arthroplasty etc.)
- •Allergy to any of the components of XP Advanced Surgical Irrigation
- •Allergy to iodine
- •Presence of concurrent active infection, primary immunodeficiency, history of uncontrolled HIV (CD4 count <200 cells/uL), treatment with immunomodulatory medications for malignancy or autoimmune disease (with exception to inflammatory arthritis), chronic glucocorticosteroid use (≥20 mg of prednisone daily for at least 1 month with another cause of immunosuppression), and solid organ and/or bone marrow transplantation.
- •History of septic arthritis to the affected joint within two years of surgery(1).
- •History of steroid injection to the affected joint within the three months preceding surgery.
- •Simultaneous bilateral total joint arthroplasty
研究组 & 干预措施
XPERIENCE Advanced Surgical Irrigation
Patients will receive the XPERIENCE Advanced Surgical Irrigation prior to wound closure.
干预措施: XPERIENCE Advanced Surgical Irrigation (Device)
Dilute Betadine
Patients will receive Dilute Betadine solution prior to wound closure.
干预措施: Dilute Betadine (Device)
结局指标
主要结局
Rate of acute (<90 days post-surgery) PJI
时间窗: 2 weeks after surgery, 3 months after surgery, within 90 day of surgery
Number of patients diagnosed with periprosthetic joint infection as per the diagnostic criteria outlined by the 2018 International Consensus Meeting of the Musculoskeletal Infection Society for Acute PJI.
次要结局
- Patient Reported Quality of Life Scores(Before surgery, 3 months after surgery, 12 months after surgery)
- Subgroup analysis of PJI rates for high-risk patients(3 months after surgery, 12 months after surgery)
- Rate of PJI at 1 year(12 months after surgery)
- Patient Reported Functional Outcome Scores(Before surgery, 3 months after surgery, 12 months after surgery)
- Rate of Superficial Wound Infections(2 weeks after surgery)
- Wound Complications (non-infection) requiring revision surgery(2 weeks after surgery)