Gut Microbiome in Orthopaedics: Investigating the Role of Gut Microbiome Composition in Total Knee Arthroplasty Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gut Microbiome Composition
研究概览
简要总结
Many patients who receive knee replacement surgery must return for a revision (or repeat) surgery due to ongoing pain, stiffness, infection, or implant loosening. The role of the gut microbiome-the collection of bacteria and other microbes within the human gastrointestinal tract-is just beginning to be recognized in orthopaedics. The gut microbiome has been found to affect the immune response and bone regulation, potentially contributing to infection or loosening after total joint replacement. Antibiotics are regularly used in orthopaedic surgery to reduce the risk of infection, yet they might also harm gut microbiota and reduce their potentially beneficial effects. As a result, understanding the relationship between gut microbiota and surgical outcomes has become increasingly important. Therefore, this study aims to determine if there are differences in gut microbiota composition between patients with well-functioning knee replacements and those requiring revision knee replacements. Additional study aims include assessing inflammation, implant loosening, metal ion levels, and circulating bacteria in blood or tissue between well-functioning or failed knee replacements.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a revision TKA
- •Willing and able to comply with follow-up requirements
- •Ability to provide informed consent
- •Ability to read, write, and speak English
排除标准
- •Pregnancy
- •Less than 3 months post-operation from primary surgery
- •Diagnosis of periprosthetic fracture
- •Scheduled for DAIR (debridement, antibiotics, and implant retention) revision surgery
- •Scheduled for stage 2 PJI revision
结局指标
主要结局
Gut Microbiome Composition
时间窗: Gut microbiome composition will be assessed pre-operatively and at 5 days and 6 weeks post-operation to determine how it changes post-operation.
The gut microbiome composition of the revision total knee arthroplasty (TKA) cohort prior to revision surgery will be compared to that of the well-functioning TKA cohort. Additionally, we will evaluate changes in the gut microbiome within the revision cohort from before surgery to six weeks after surgery.
次要结局
- Inducible Displacement Measurements with Weight-Bearing Computed Tomography (WBCT)(WBCT exams will be performed at one timepoint prior to the study participant's revision surgery.)
- Inflammation in the Knee Joint Based on [18F]FEPPA Standard Uptake Values (SUV)(PET/CT exams will be performed at one timepoint prior to the study participant's revision surgery.)
研究者
Brent Lanting
Orthopaedic Surgeon
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
