Prospective Study of Patients Treated for Prosthetic Hip Infection and Followed for at Least 2 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 347
- 试验地点
- 1
- 主要终点
- Incidence of reinfection (relapse and new infection)
研究概览
简要总结
Data from large prospective cohort studies of prosthetic joint infections are lacking.
Aim of this study: analyzing prospectively the incidence of reinfection in patients with prosthetic hip infections who underwent surgery and received antibiotic therapy.
Hypothesis: to confirm in a large group that the incidence of reinfection after excision -synovectomy in acute prosthesis hip infection is 30% and 15% for chronic infection after exchange arthroplasty (one or two stage exchange).
详细描述
Aim of the study: to analyze the incidence of reinfection in patients with prosthetic hip infection who underwent surgery and received antibiotic therapy Methods: prospective cohort study in a French referral center for osteoarticular infections from November 2002 to March 2010. Population
- all patients who consented to participate in the study with prosthetic hip infections treated by:
- debridement-synovectomy for acute infection or with one-stage or two-stage
- exchange arthroplasty or resection arthroplasty for chronic infection
- antibiotic therapy
Outcome:
- Follow-up: minimum of 2 years
- Events monitored: reinfection including relapse and new infection, joint revision for mechanical reasons, prosthetic hip infection related and non-related deaths
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 hip arthroplasty infection
- •Surgical treatment: either debridement-synovectomy and prosthesis retention for acute infection or one or two-stage exchange arthroplasty or resection arthroplasty for chronic infection
- •Antibiotic therapy
- •Signed informed consent
排除标准
- •Prolonged suppressive antibiotic therapy
- •No surgical treatment
结局指标
主要结局
Incidence of reinfection (relapse and new infection)
时间窗: 2 years
The aim of this study was to prospectively determine the incidence of reinfection in patients with prosthetic hip infection after two years of follow up.
次要结局
- Incidence and causes of mechanical revision(2 years)
- Incidence and causes of death: infection or treatment related death, unrelated death(2 years)
研究者
Dr Valerie ZELLER
Investigator coordinator
Groupe Hospitalier Diaconesses Croix Saint-Simon