Antibiotic Impregnated Bone Graft to Reduce Infection in Hip Replacement. The ABOGRAFT Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,100
- 试验地点
- 2
- 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
Total hip replacement is the most successful treatment modern healthcare can offer patients to regain quality of life. Periprosthetic joint infection (PJI) is the most common and devastating complication after total hip replacement (THR). Between 0.5 to 2% of primary THR (first time hip replacement), and 8-10% of revision THR (replacement of a hip prosthesis) will become infected.1 The introduction of local antibiotics blended into bone cement has led to a reduction in postoperative infection in primary THR by half.2 Unfortunately, cement can't always be used in relevant quantities.
The number of primary and revision surgeries of the hip is projected to increase dramatically. Therefore, the need for a feasible infection prophylaxis that is applicable for complex primary and revision THR in addition to antibiotics loaded cement is urgent.
Impacted morselized bone allograft is often used in (revision) THR to fill bone defects. Morselized allograft has been used as a carrier for local antibiotic treatment in multiple pilot studies and appears to be an attractive and effective treatment option, both for already infected joints and as a prophylactic measure in high-risk patients (e.g. THR revision surgeries). Nonetheless, a pivotal trial to support its use in THR is lacking. The aim of this pragmatic randomized controlled double blinded drug trial is to investigate whether antibiotic impregnated bone graft (AIBG) decreases the risk of infection after hip arthroplasty compared to controls treated with placebo impregnated bone graft. Patients scheduled for elective THR will be randomized to receive AIBG or a placebo impregnated bone graft. The primary outcome variable will be the number of re-operations due to infections and PJI diagnoses 2 years postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blinded
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
- •Age ≥ 18 years
- •Hip arthroplasty requiring bone graft
- •Willing to provide informed consent.
- •For women of childbearing potential; a negative pregnancy test prior to surgery.
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
研究组 & 干预措施
Placebo
Saline locally added to allograft and locally administered during revision surgery after total hip arthroplasty.
干预措施: Saline (Drug)
Treatment arm
Combination of vancomycin and tobramycin mixed with allograft and locally administered during revision surgery after total hip arthroplasty.
干预措施: Vancomycin + Tobramycin (Drug)
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.
时间窗: 2 years after finalizing data collection.
Reoperation due to infection or diagnosed PJI 2 years of revision surgery.
Time to 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.
时间窗: 2 years after finalizing data collection.
Reoperation due to infection or diagnosed PJI 2 years after index surgery.
次要结局
- Time and cause for reoperation for any reason within 2 and 5 years(2 and 5 years after finalizing data collection.)
- Time and cause for implant revision due to any reason within 2 and 5 years(2 and 5 years after finalizing data collection.)
- Type of microbe and antibiotic resistance pattern for cases complicated with postoperative infection(2 and 5 years after finalizing data collection.)
- Time to reoperation due to infection or diagnosis of PJI with any microorganism in the same hip joint within 2 years after THA.(All infections within 2 years after index surgery.)
- Time to and cause for reoperation for any reason within 2 and 5 years(2 and 5 years after finalizing data collection.)
- Time to and cause for implant revision due to any reason within 2 and 5 years(2 and 5 years after finalizing data collection.)
- Type of microorganism and antimicrobial susceptibility pattern for cases with postoperative infection(2 and 5 years after finalizing data collection.)
研究者
Jörg Schilcher
Professor
University Hospital, Linkoeping