Antibiotic-Loaded Cement Versus Non-Antibiotic-Loaded Cement in Hip Prosthesis Surgery for Proximal Femur Fractures: A Prospective, Randomized, Single-Center, Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Incidence of Acute Postoperative Infections
研究概览
简要总结
The study aims to determine if antibiotic-loaded cement reduces post-surgery infection rates compared to non-antibiotic cement. The trial involves 450 elderly patients with specific hip fractures, assessing infection incidence, implant stability, and associated costs. This randomized, blinded study is conducted by IRCCS Ospedale San Raffaele.
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, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be older than 65 years
- •Fracture Type: The study includes patients with medial femoral neck fractures classified as AO type B1, B2, and B3, indicating specific types of hip fractures.
- •Surgical Indication: Patients should have an indication for prosthetic hip surgery.
- •Informed Consent: Patients must provide signed informed consent to participate in the study
排除标准
- •Fracture Type: Exclusion of patients with trochanteric region fractures and femoral head fractures (AO classification types A and C), periprosthetic fractures, patients with multiple traumas or multiple fractures.
- •Blood Test Anomalies: Patients with pre-operative blood test anomalies, such as ionic disorders and hemoglobin levels lower than 8 g/dL.
- •Renal Insufficiency: Patients with renal insufficiency.
- •Active Infections: Exclusion of patients with active infections or suspected/confirmed hypersensitivity or allergy to gentamicin, history of toxicity or reaction to aminoglycosides.
研究组 & 干预措施
Intervention
(Antibiotic-Loaded Cement Arm): This group will receive hip prosthesis surgery using antibiotic-loaded cement. The use of antibiotic-loaded cement is intended to investigate its effectiveness in reducing the rate of acute postoperative infections.
干预措施: Antibiotic loaded (Drug)
control
(Non-Antibiotic-Loaded Cement Arm): Participants in this group will undergo hip prosthesis surgery using non-antibiotic-loaded cement. This arm serves as the control to compare the outcomes with the antibiotic-loaded cement group.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of Acute Postoperative Infections
时间窗: 7 days post surgery
This outcome measure focuses on the rate of acute infections occurring postoperatively in patients undergoing hip prosthesis surgery. The study will compare the incidence of such infections between the two groups: one receiving antibiotic-loaded cement and the other receiving non-antibiotic-loaded cement. An acute infection is typically defined based on clinical signs, laboratory markers of infection (like elevated C-reactive protein levels, white blood cell count, etc.), and the need for any additional interventions or treatments due to infection.
次要结局
未报告次要终点
研究者
Professor Giacomo Placella
Professor
Università Vita-Salute San Raffaele