Arthrotomy With Irrigation and Debridement Versus Serial Arthrocentesis as Treatment for Septic Arthritis in Adults
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Eradication of infection at 2 months
研究概览
简要总结
Joint spaces are aseptic areas, meaning that they do not contain microorganisms. Any injury to the joint space could cause the entry of microorganisms, with the potential to cause infection. Septic arthritis refers to the infection of a joint space with microorganisms, usually bacteria. This invasion initiates a process of inflammation and causes irreversible damage to a joint cavity. Patients typically present with pain, swelling, decreased motion, and inability to use the joint. When bacteria enter a joint space, the host immune system responds by concentrating inflammatory cells within the joint. While inflammatory cells serve to eliminate the bacteria, they also produce substances that not only attack bacteria but also could destroy the joint space. These substances are called enzymes, and they could damage the cartilage (translucent fairly elastic tissue around the joint) and adjacent bone in the process. Because cartilage has a poor ability to cure itself, this process may lead to irreversible damage and chronic joint dysfunction. Studies have found that signs of early joint damage can be found within hours following joint infection. This is true even if antibiotic therapy (medicine to fight the infection) is started within 24 hours of infection. Also, delay in treatment has been related to poor outcome. However, the best method of treating septic arthritis has yet to be determined. Currently, there are two accepted ways for treating septic arthritis: serial needle aspiration (introducing a needle in the joint to aspirate the inflammatory liquid), and surgical lavage (opening and cleaning the joint space in the OR under anesthesia). Antibiotics are also used with these two forms of treatment. Supporters of surgery believe that the most dependable method of eliminating bacteria from a joint space is through arthrotomy (opening the joint with a surgical incision) and lavage (irrigation of the joint with copious saline solution) .Promoters of serial needle aspiration support this method because it is quick, does not require opening the joint space, and can be performed without anesthesia.At present, there are no conclusive studies comparing the two techniques. Hopefully, this study will help delineate the best course of management.
详细描述
The principle objectives and justification for this study:
To determine whether arthrotomy with irrigation and debridement or repeated arthrocentesis provides a clear benefit over the other for the treatment of septic arthritis in adults.
Background:
Septic arthritis is an infection with consequential inflammation of a joint space by various microorganisms. Typically it is bacterial in origin and results by hematological seeding or direct invasion of a joint space. This invasion initiates a cascade of inflammation and causes irreversible damage to a joint cavity. Patients typically present with edema, erythema, substantial decrease in range of motion, and the inability to use the joint. It remains a significant medical issue accounting for 0.2-0.7% of hospital admissions in the United States with a mortality rate ranging from 2-14%.
Once bacteria enter a joint space it produces a purulent fluid that induces an acute inflammatory response. The body's inflammatory cells, although aids in eradicating the bacteria, produces enzymes that also damage extracellular cartilage matrix, synovium, and adjacent bone in a relatively short period of time.1,2 Because adult cartilage has poor regenerative capabilities, this process leads to irreversible damage and chronic joint dysfunction.4 Studies have found that signs of early joint damage can be found within hours following joint infection.1, 5 This is true even if antibiotic therapy is started within 24 hours of infection. Also, delay in initiation of treatment has repeatedly found to be a major determinant of poor outcome.6 Thus, it is well accepted that early drainage of purulent material in addition to antibiotics is imperative for preventing irreparable articular damage.4 However, the best method for doing so has yet to be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 with acute onset of symptoms of less than or equal to two weeks' duration.
- •Patients with infection of only the following joints: ankle, knee, hip, wrist, elbow, or shoulder
- •Patients with proven bacterial infection by positive gram stain or culture of synovial fluid and with white blood cell count in synovial flood consistent with infection (75,000 - 150,000 cells/mm3.)
- •Cases with negative synovial fluid cultures if positive blood cultures are present and associated with typical inflammatory synovial fluid changes without other identifiable sources of infection and if antibiotic therapy had been initiated earlier to explain negative synovial fluid cultures.
- •Monoarticular arthritis
排除标准
- •Gonococcal infections
- •Infected prosthetic joints
- •Adjacent osteomyelitis preceding joint infection
- •Septic arthritis occurring as an incidental event late in the course of otherwise fatal illness
- •Patients that are 17 years old or less.
- •Polyarticular arthritis.
结局指标
主要结局
Eradication of infection at 2 months
次要结局
未报告次要终点