EUCTR2021-001708-14-SE进行中（未招募）1 期
Antibiotic Impregnated Bone Graft to reduce infection in revision hip replacement. The ABOGRAFT trial - ABOGRAFT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •* Age = 18 years
- •* Hip arthroplasty requiring reoperation or revision with bone graft
- •* Willing to provide informed consent.
- •* For women of childbearing potential; a negative pregnancy test prior to reoperation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 240
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 960
排除标准
- •* Patients with prosthetic joint infection as the reason for the reoperation
- •* Known allergies and contraindications for the use of vancomycin or tobramycin
- •* Mental inability, reluctance or language difficulties that according to investigator judgement, result in difficulty understanding the meaning of study participation
- •* Expected difficulties to complete 2-year follow-up
- •* Women of child bearing potential not using contraception
- •* Pregnant women
- •* Nursing women
研究者
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