HIPrevision - A Randomized Multicenter Clinical Investigation of Antimicrobial IP-Coated Revision Hip Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Aesculap AG
- 入组人数
- 268
- 试验地点
- 3
- 主要终点
- Occurrence of periprosthetic joint infections
研究概览
简要总结
The primary aim of the clinical investigation is to demonstrate the efficacy of a silver-based antimicrobial coating on hip implants in the reduction of periprosthetic infections in revision hip arthroplasty due to periprosthetic infection.
详细描述
The clinical investigation will include patients indicated for revision hip arthroplasty due to chronic periprosthetic infection. Subjects will either receive standard CE-marked revision hip implants or the newly developed IP (Infection prevention)- coated revision hip implants. The primary clinical benefit of the IP hip implant components remains the functional restoration of the hip joint and pain relief, as successfully shown for the uncoated predecessor devices, but additionally the IP coating is regarded ancillary to the intended purpose of the implant. Periprosthetic infections are one of the major complications in revision hip arthroplasty, leading to implant re-revision. A clinical investigation to evaluate additional measures to reduce this complication rate in revision total hip arthroplasty therefore has high clinical relevance.
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
- Double (Participant, Outcomes Assessor)
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
- •Patients > 18 years
- •Patients indicated for unilateral cementless acetabular and hip stem revision due to chronic periprosthetic infection (according to EBJIS definition): single-stage or two-stage surgical procedure according to clinical standard at the clinical investigation site
- •According to the assessment of the clinical investigator, the subject is therapy compliant and able to attend the follow-up visits
- •ASA physical status I - III
- •Patient's signed written informed consent is available
排除标准
- •Simultaneous participation in another interventional clinical trial (drugs or medical devices studies)
- •The investigational implant components (femoral and/or acetabular) are not suitable for the patient anatomy or bone defect
- •Patients who require plate osteosynthesis at the implantation site
- •Patients with an already implanted silver-coated device
- •Patients with immunodeficiency, i.e. patients currently receiving immunosuppressive therapy or patients with severe immunodeficiency requiring drug therapy
- •Patients currently undergoing cancer treatment, e.g. chemotherapy or radiation therapy
- •Severe soft tissue defects that require local or free flap procedure
- •Periprosthetic joint infections with evidence of fungal infection
- •Antibiotic suppression therapy
- •BMI > 40 kg/m2
- •Pregnancy, breast-feeding, or women of childbearing potential and not taking adequate contraceptive precautions
- •Known or patient reported hypersensitivity to silver or titanium
- •Patients held in a custodial setting
- •Patients in a relationship of dependence on the sponsor, the clinic or the investigator
- •Patients with contraindication for the investigational and comparator devices:
- •in case of secondary diseases influencing the function of the joint implant
- •in case of severe osteoporosis or osteomalacia
- •in case of poor bone quality and osseous malformations, diseases in the area of the implant fixation, which may primarily or subsequently affect the stability of the joint replacement anchorage
- •in case of non-regenerative bone conditions with lack of proximal femoral bone support and failure of defect union when use of prosthesis heads with neck length XXL is indicated
结局指标
主要结局
Occurrence of periprosthetic joint infections
时间窗: 12 months
Participants are monitored for 12 months after revision surgery. Every case of periprosthetic joint infection according to the definition of the EBJIS classification counts.
次要结局
- Change of functional outcome over follow-up period (Harris Hip Score (HHS))(2 years post operative)
- Changes in quality of life(2 years post operative)
- Implant survival(2 years post operative)
- Radiographic assessment(2 years post operative)
- Occurrence of safety issues with the new device(2 years post operative)
- Level of silver ion concentration(12 months)
- Changes in blood biomarkers for liver function(12 months)
- Changes in blood biomarker for kidney function(12 months)
- Changes in blood biomarker for inflammation(12 months)