2024-510921-25-00招募中2 期
Antibiotic Impregnated Bone Graft to reduce infection in hip replacement - the ABOGRAFT trial
Region Oestergoetland10 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2024年3月19日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 850
- 试验地点
- 10
- 主要终点
- Reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty
研究概览
简要总结
To investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection 2 years after hip arthroplasty, compared to controls treated with placebo impregnated bone graft.
研究设计
- 分配方式
- Randomized
- 主要目的
- Antibiotic Impregnated Bone Graft to reduce infection in hip replacement. The ABOGRAFT trial.
- 盲法
- Double (Investigator, Carer, Subject, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Hip arthroplasty requiring bone graft
- •Willing to provide informed consent
- •For females of childbearing potential; a negative pregnancy test prior to reoperation
排除标准
- •Ongoing prosthetic joint infection
- •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
- •Females of child bearing potential not using contraception
- •Pregnant females
- •Nursing females
结局指标
主要结局
Reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty
Reoperation due to infection or diagnosed PJI with bacteria that are sensitive to either vancomycin or tobramycin, in the same hip joint, within two years after hip arthroplasty
次要结局
- Time and cause for reoperation for any reason within 2 and 5 years
- Time and cause for implant revision due to any reason within 2 and 5 years
- Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection
- Differences between the two experimental groups regarding the frequencies of adverse events
- Differences between the two experimental groups regarding the rates of revision due to aseptic loosening
研究者
Jörg Schilcher
Scientific
Region Oestergoetland
研究点 (10)
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