Construction of a Multicenter Disease-Specific Database and Prospective Cohort for Osteomyelitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Infection control rate at week 8 after treat
研究概览
简要总结
To establish a prospective, multicenter, real-world cohort of patients with osteomyelitis, by systematically collecting and analyzing detailed treatment and follow-up data, in order to provide clinical evidence for the standardization of its treatment
详细描述
Study Design： This is a prospective, multi-center, real-world clinical study. Subjects will be assigned to different treatment regimens based on their diagnosis and differential diagnosis.
Conservatively Treated Cohort: Patients with bone infection who do not meet the criteria for surgical intervention will receive conservative therapy, which includes intravenous (IV) and oral antibiotics.
Surgically Treated Cohort: Patients meeting the surgical indications will undergo a staged surgical protocol. The first stage involves debridement and implantation of antibiotic-impregnated bone cement. The need for auxiliary internal or external fixation will be determined based on the patient's condition. The second stage, performed 8 weeks after the first, focuses on repairing the bone defect.
All treatments will be conducted in accordance with current clinical practice guidelines. This study is purely observational; it will only monitor and collect data on changes in relevant parameters during the treatment process without interfering with any other clinical decisions.
Data Collection：
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent provided.
- •Diagnosis of osteomyelitis confirmed by the site per guidelines (including definitive/suggestive criteria).
排除标准
- •Patients who, in the opinion of the investigator, are unable to comply with the entire study procedure (including postoperative management and regular follow-up) due to psychiatric, cognitive, or behavioral disorders, or other objective reasons.
- •Any other condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the study.
结局指标
主要结局
Infection control rate at week 8 after treat
时间窗: 8 weeks after operation
Patients will return for a follow-up visit at 8 weeks post-treatment. The assessment will include evaluation of the incision condition, documentation of afebrile status, and repeat laboratory tests including CBC (WBC count), ESR, and CRP
次要结局
- Disability of Arm Shoulder and Hand Scale（DASH）(Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment)
- The 36-Item Short Form Health Survey(Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment)
- Self-Rating Anxiety Scale (SAS)(Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment)
- Pain score (assessed by Visual Analogue Scale)(Pre-treatment;At 2 weeks post-treatment; At 8 weeks post-treatment; At 12 months post-treatment)
- Lower Extremity Functional Scale(Pre-treatment; At 8 weeks post-treatment; At 12 months post-treatment)
研究者
Dong Sun
Associate Professor
Southwest Hospital, China