NCT02107924撤回不适用
Use of Antibiotic Contained Calcium Sulfate Carrier in Acute Periprosthetic Infections(APPI) of Total Knee Replacements
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Retention of components
研究概览
简要总结
The purpose of the study is to gather information on the use of Stimulan, the surgery, and anitbiotics to whetether the APPI has decreased or shown improvement when compared to study participants who did not receive Stimulan during their revision total knee replacement surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •APPI within 28 days of primary TKR
- •Acute hematogenous infection within 4 weeks of symptoms
排除标准
- •Exposed prosthesis
- •Infection occuring in revised joints
- •Poly articular infections
- •have allergies to tobramycin or Vancomycin
- •previous chronic infections in or around any ipsilateral extremity trauma or implants
结局指标
主要结局
Retention of components
时间窗: 12 months
Eradication of infection
时间窗: 12 months
次要结局
- Outcome Assessment Scores(12 months)
- Ongoing use of antibiotics(6 weeks)
- AP and lateral Radiographs of involved joint(12 months)
- Positive synovial fluid cell count(pre-operative)
- Sedimentation Rate(12 months)
- C-Reactive protein (CRP)(12 months)
- Wound complications(12 months)
- Knee Society Score(12 months)
- Visual Analog Scale(12 months)
研究者
Michael Muldoon, M.D.
Co-Sponsor
Sharp HealthCare
研究点 (1)
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