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临床试验/NCT06951477
NCT06951477尚未招募不适用

Gut Microbiome in Orthopaedics: Investigating the Role of Gut Microbiome Composition in Total Knee Arthroplasty Failure

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年10月1日最近更新:
适应症

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

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

发起方
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brent Lanting

Orthopaedic Surgeon

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (1)

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