Gut Microbiome in Orthopaedics: Revision Total Knee Arthroplasty

Официальное название

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

Обзор

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.

Вмешательства

• Процедура Revision Total Knee Arthroplasty
  Study participants must be scheduled to receive a revision TKA.

Первичные конечные точки

• Gut Microbiome Composition [Срок оценки: Gut microbiome composition will be assessed pre-operatively and at 5 days and 6 weeks post-operation to determine how it changes post-operation.]

Вторичные конечные точки (2)

• Inducible Displacement Measurements with Weight-Bearing Computed Tomography (WBCT) [Срок оценки: 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) [Срок оценки: PET/CT exams will be performed at one timepoint prior to the study participant's revision surgery.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 1 центр

• University Hospital — London

Публикации

• Hext RA, Kaptein BL, Howard JL, Lanting BA, Teeter MG. Inducible displacement of cementless total knee arthroplasty components with conventional and weight-bearing CT-based radiostereometric analysis. J Orthop Res. 2025 Mar;43(3):640-649. doi: 10.1002/jor.26017. Epub 2024 Nov 15. PMID 39545647
• Xiao PL, Hsu CJ, Ma YG, Liu D, Peng R, Xu XH, Lu HD. Prevalence and treatment rate of osteoporosis in patients undergoing total knee and hip arthroplasty: a systematic review and meta-analysis. Arch Osteoporos. 2022 Jan 14;17(1):16. doi: 10.1007/s11657-021-01055-9. PMID 35029750
• Li J, Ho WTP, Liu C, Chow SK, Ip M, Yu J, Wong HS, Cheung WH, Sung JJY, Wong RMY. The role of gut microbiota in bone homeostasis. Bone Joint Res. 2021 Jan;10(1):51-59. doi: 10.1302/2046-3758.101.BJR-2020-0273.R1. PMID 33448869
• Hernandez CJ, Yang X, Ji G, Niu Y, Sethuraman AS, Koressel J, Shirley M, Fields MW, Chyou S, Li TM, Luna M, Callahan RL, Ross FP, Lu TT, Brito IL, Carli AV, Bostrom MPG. Disruption of the Gut Microbiome Increases the Risk of Periprosthetic Joint Infection in Mice. Clin Orthop Relat Res. 2019 Nov;477(11):2588-2598. doi: 10.1097/CORR.0000000000000851. PMID 31283731
• Chisari E, D'Mello D, Sherman MB, Parvizi J. Inflammatory Bowel Diseases Increase the Risk of Periprosthetic Joint Infection. J Bone Joint Surg Am. 2022 Jan 19;104(2):160-165. doi: 10.2106/JBJS.20.01585. PMID 34648464
• Hernandez CJ. Musculoskeletal Microbiology: The Microbiome in Orthopaedic Biomechanics. Curr Opin Biomed Eng. 2021 Sep;19:100290. doi: 10.1016/j.cobme.2021.100290. Epub 2021 May 6. PMID 34151053
• Moran MM, Wessman P, Rolfson O, Bohl DD, Karrholm J, Keshavarzian A, Sumner DR. The risk of revision following total hip arthroplasty in patients with inflammatory bowel disease, a registry based study. PLoS One. 2021 Nov 4;16(11):e0257310. doi: 10.1371/journal.pone.0257310. eCollection 2021. PMID 34735461
• Abdeen A, Della Valle CJ, Kendoff D, Chen AF. The Paradox of Prosthetic Joint Infection and the Microbiome: Are Some Bacteria Actually Helpful? Arthroplast Today. 2022 Jan 18;13:116-119. doi: 10.1016/j.artd.2021.11.011. eCollection 2022 Feb. PMID 35106346

Идентификаторы

NCT: NCT06951477 · 126857

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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