Clinical trial NCT06951477: Gut Microbiome in Orthopaedics: Revision Total Knee Arthroplasty
Official title: Gut Microbiome in Orthopaedics: Investigating the Role of Gut Microbiome Composition in Total Knee Arthroplasty Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Revision Total Knee Arthroplasty
Osteoarthritis, Knee
Keywords: Revision TKA
Gut Microbiome
Implant Loosening
Inflammation
Weight-Bearing Computed Tomography
PET/CT
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at University Hospital scheduled to undergo a revision TKA.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Gut Microbiome Composition
timeFrame: Gut microbiome composition will be assessed pre-operatively and at 5 days and 6 weeks post-operation to determine how it changes post-operation.
Secondary outcomes:
measure: Inducible Displacement Measurements with Weight-Bearing Computed Tomography (WBCT)
timeFrame: WBCT exams will be performed at one timepoint prior to the study participant's revision surgery.
measure: Inflammation in the Knee Joint Based on [18F]FEPPA Standard Uptake Values (SUV)
timeFrame: PET/CT exams will be performed at one timepoint prior to the study participant's revision surgery.
Other outcomes:
measure: Inducible Displacement and Microbiome Composition
timeFrame: Inducible displacement exams will be performed pre-operatively and will be compared to the gut microbiome from pre-operation to 6 weeks post-operation, and to the intra-operative joint microbiome.
measure: Implant Wear Volume and Within-Bone Implant Motion from Inducible Displacement Exams
timeFrame: Inducible displacement exams will be performed pre-operatively and will be compared to the amount of wear that has occurred on implants retrieved during revision surgery.
measure: Metal Ion Levels and Within-Bone Implant Motion from Inducible Displacement Exams
timeFrame: Inducible displacement exams will be performed pre-operatively and will be compared to the amount of circulating metal ions pre-operation.
measure: [18F]FEPPA Activity and Microbiome Composition
timeFrame: PET/CT exams will be performed pre-operatively and will be compared to the gut microbiome from pre-operation to 6 weeks post-operation, and to the intra-operative joint microbiome.
measure: [18F]FEPPA Activity and Implant Wear Volume
timeFrame: PET/CT exams will be performed pre-operatively and will be compared to the amount of wear that has occurred on implants retrieved during revision surgery.
measure: [18F]FEPPA Activity and Metal Ion Levels
timeFrame: PET/CT exams will be performed pre-operatively and will be compared to the amount of circulating metal ions pre-operation.
Locations:
city: London
country: Canada
facility: University Hospital
state: Ontario
Study officials:
affiliation: Schulich School of Medicine & Dentistry
name: Brent Lanting, MD, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
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