Outcomes of Surgical Treatment of Osteoarticular Infections Using Bioactive Bone Substitute Impregnated With Antibiotics: Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 主要终点
- Comparative rate of infection recurrence
研究概览
简要总结
This prospective research project aims to evaluate the effectiveness and clinical outcomes of utilizing antibiotic-impregnated bioactive bone substitute (PerOssal®) in the surgical management of osteoarticular infections. Osteoarticular infections pose significant challenges in orthopaedic surgery due to the risk of persistent infection, bone loss, and functional impairment. Traditional treatment approaches involve extensive debridement followed by systemic antibiotic therapy and bone grafting. However, antibiotic-impregnated bioactive bone substitutes offer a promising alternative by providing local antibiotic delivery and promoting bone regeneration simultaneously. This study will prospectively enrol patients undergoing surgical intervention for osteoarticular infections and assess their clinical outcomes, including infection resolution, bone healing, functional recovery, and complication rates. Comprehensive data collection will include preoperative patient characteristics, intraoperative details, postoperative outcomes, and long-term follow-up assessments. Statistical analyses will be performed to compare outcomes between patients treated with antibiotic-impregnated bioactive bone substitute and those past managed with traditional methods. The findings of this study are expected to contribute valuable insights into the effectivennes and safety of this novel approach, potentially informing future clinical practices and optimizing patient care in the management of osteoarticular infections.
详细描述
Background:
Osteoarticular infections represent a significant challenge in orthopedic surgery, posing substantial morbidity and potential mortality if not adequately managed. These infections can arise from various sources, including hematogenous spread, contiguous spread from adjacent soft tissue or bone, or direct inoculation during trauma or surgery. Common pathogens associated with osteoarticular infections include Staphylococcus aureus, coagulase-negative staphylococci, Streptococcus species, and gram-negative bacilli, among others.
The management of osteoarticular infections typically involves a combination of surgical intervention and antimicrobial therapy. Surgical treatment aims to achieve complete debridement of infected tissue, removal of necrotic bone, and restoration of skeletal integrity. However, achieving adequate debridement and local antibiotic delivery while preserving bone stock remains a challenge.
Traditional approaches to bone defect management often rely on autografts, allografts, or synthetic bone substitutes. While these methods have demonstrated efficacy in promoting bone healing, they may not address the specific challenges posed by osteoarticular infections, particularly in terms of infection eradication and local antibiotic delivery.
In recent years, there has been growing interest in the use of antibiotic-impregnated bioactive bone substitutes for the management of osteoarticular infections. These materials offer several potential advantages over traditional approaches. Firstly, they provide a scaffold for bone regeneration, promoting osteogenesis and osteoconduction. Secondly, they have the capacity to release antibiotics locally, achieving high concentrations at the site of infection while minimizing systemic exposure and potential adverse effects. Thirdly, they can fill osseous defects and provide structural support, facilitating functional recovery.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All fracture-related infections (clinical and laboratory/microbiological diagnosis).
- •Patients > 12 years old.
- •Surgical treatment with indication for local antibiotic use.
排除标准
- •Other modalities of musculoskeletal infection (arthroplasties, hematogenous osteomyelitis, septic arthritis, infections related to bone tumors).
- •Unconfirmed diagnosis of infection.
结局指标
主要结局
Comparative rate of infection recurrence
时间窗: 1 YEAR
次要结局
- Pain score using numeric pain scale (0 - no pain; 10 - worst pain)(6,12, 24, 48 WEEKS)
- Duration of systemic antibiotic usage(up to 12 weeks)
- Microbiological profile of infections(up to 1 week)
- QUALITY OF LIFE USING EuroQol-5D (EQ-5D)(6,12, 24, 48 WEEKS)
- General complications (other than infection recurrence)(6,12, 24, 48 WEEKS)
- Length of hospital stay(through study completion, an average of 1 year)
研究者
GUILHERME GUADAGNINI FALOTICO
Professor
Federal University of São Paulo