DRKS00034162尚未招募Unknown
se of bone cement versus bone substitute material in two-stage replacement of septic hip endoprostheses
udwig-Maximilians-Universität München-Klinikum, Klinik für Orthopädie und Unfallchirurgie, Muskuloskelettales Universitätszentrum München (MUM)0 个研究点目标入组 20 人开始时间: 2024年5月8日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. Patients diagnosed with periprosthetic joint infection with hip arthroplasty in place, according to the EBJIS definition of periprosthetic joint infection
- •2. Male or female patients aged 18-75 years
- •3. Patients undergoing two-stage treatment for periprosthetic infection: Change of hip prosthesis is planned
- •4. Life expectancy of at least 1 year
- •5. The patient is willing to give informed consent and is able or sufficiently compliant to comply with the planned follow-up examinations, tests and medications.
排除标准
- •1. Individuals who are unable to give informed consent to participate in the study or who are unwilling to give consent to participate in the study
- •2. Pregnant or breastfeeding women or women planning to do so during to become pregnant during the study period
- •3. Patients who are currently participating in a study of another drug or medical device or have previously been included in this study NOTE: Participation in another clinical study during the follow-up period is not permitted.
- •4. The presence of one of the contraindications listed in the current instructions for use of the test products CERAMENT G or CERAMENT V, or the instructions for use of Copal C/V
- •5. Patients with a confirmed multibacterial periprosthetic infection (= more than 1 phenotypically distinguishable pathogen) or a confirmed one Infection with fungi or vancomycin-resistant enterococci (VRE) or multidrug-resistant gram-negative bacteria (MRGN III and IV)
- •6. Patients who have undergone more than one previous operation on the affected hip joint
研究者
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