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Gut Microbiome in Orthopaedics: Revision Total Knee Arthroplasty (GUMBO)

L

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

Status

Not yet enrolling

Conditions

Revision Total Knee Arthroplasty
Osteoarthritis, Knee

Treatments

Procedure: Revision Total Knee Arthroplasty

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Revision TKA
Description:
Participants scheduled to undergo a revision TKA will be recruited. They must be more than 3 months post-operation from their primary surgery, and the revision must be for something other than periprosthetic fracture, DAIR (debridement, antibiotics, and implant retention), or stage 2 periprosthetic joint infection.
Treatment:
Procedure: Revision Total Knee Arthroplasty

Trial contacts and locations

1

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Central trial contact

Brent Lanting, MD, MSc, FRCSC; Lyndsay Somerville, PhD

Data sourced from clinicaltrials.gov

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