Epidemiology, Risk Factors, and Outcomes of Infections of Lower Limb MEGAprostheses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percent of patients with and without a diagnosis of megaprosthesis infection
研究概览
简要总结
Retrospective, multicenter, non-profit observational study. The study will include consecutive patients who underwent lower-limb megaprosthesis implantation at the participating Centers between January 1, 2020, and June 30, 2023.
详细描述
Megaprostheses are large orthopedic prostheses used to replace extensive portions of bone and joints, typically after the removal of bone tumors or in other conditions involving major bone loss (severe trauma, revisions). In the 1990s, they became the standard for reconstruction following resection of primary malignant bone tumors. Over time, the indications for the use of megaprostheses have expanded to include benign but locally aggressive bone tumors, bone metastases, and malignant soft tissue tumors. Currently, the number of megaprosthesis procedures for non-oncologic conditions is also increasing.
The anatomical sites where a megaprosthesis can be implanted include the femur (proximal, distal, or total), the proximal tibia, and the proximal humerus. Megaprostheses are modular metal structures (titanium, chrome-cobalt) that may include an artificial bone segment, a joint component (hip, knee, shoulder), and potentially an antibacterial coating (such as silver).
While a megaprosthesis represents an important therapeutic option for limb salvage, it also involves complex surgery with significant complication and failure rates. Periprosthetic infection, with incidence rates ranging from 3% to 30%, is certainly one of the most feared complications, as it is associated with increased morbidity and mortality, longer patient recovery times, and higher healthcare costs. Revising a megaprosthesis often presents additional technical challenges for orthopedic surgeons (for example, the impossibility of replacing the implant due to the lack of remaining tissues). Moreover, the rate of infectious complications in megaprostheses is higher than that of periprosthetic infections in standard joint replacements. Possible explanations include longer surgical times, greater soft tissue trauma, or patient-related factors (such as immunocompromised status in oncologic patients).
The use of megaprostheses to treat different types of lower-limb conditions is increasing, and these prostheses carry a higher risk of infection compared to standard implants.
There is a shortage of studies in the literature that specifically and thoroughly analyze risk factors for megaprosthesis infections, and existing studies often involve small patient cohorts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 14 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 14 years
- •Implantation of a lower-limb megaprosthesis at one of the participating centers between January 1, 2020, and June 30, 2023
- •At least 2 years of follow-up after megaprosthesis implantation
- •Signed informed consent
排除标准
- 未提供
研究组 & 干预措施
Patients who underwent lower-limb megaprosthesis implantation
All patients aged 14 years or older who underwent implantation of a lower-limb megaprosthesis at the participating Centers between January 1, 2020, and June 30, 2023
结局指标
主要结局
Percent of patients with and without a diagnosis of megaprosthesis infection
时间窗: 24 months after prosthesis placement
Distribution of the study variables in the two groups of patients with and without megaprosthesis infection
次要结局
- Number of patients diagnosed with lower-limb megaprosthesis infection / number of patients who received a lower-limb megaprosthesis(24 months after prosthesis placement)
- Sex, Charlson index, indication for prosthesis placement, symptoms and etiology of the infection in patients diagnosed with megaprosthesis infection(During prosthesis placement procedure and at the time of diagnosis of the megaprosthesis infection (assessed up to 2 months after prosthesis placement))
- Age of patients diagnosed with megaprosthesis infection(During prosthesis placement procedure and at the time of diagnosis of the megaprosthesis infection (assessed up to 2 months after prosthesis placement))
- Number and type of surgical procedures performed for the treatment of megaprosthesis infection(Within 24 months after prosthesis placement)
- Sex of patients diagnosed with megaprosthesis infection(During prosthesis placement procedure and at the time of diagnosis of the megaprosthesis infection (assessed up to 2 months after prosthesis placement))
- Number and type (molecule(s), route of administration, dosage, duration) of antibiotic treatments prescribed for the treatment of megaprosthesis infection(Within 24 months after prosthesis placement)
- Percent of patients with megaprosthesis infection who experience clinical failure(24 months after prosthesis placement)
- Charlson index in patients diagnosed with megaprosthesis infection(During prosthesis placement procedure and at the time of diagnosis of the megaprosthesis infection (assessed up to 2 months after prosthesis placement))