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Revision Total Knee ArthroplastyGUMBONCT06951477

Gut Microbiome in Orthopaedics: Revision Total Knee Arthroplasty

An observational study of Revision Total Knee Arthroplasty and Osteoarthritis, Knee, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Any age
What is being tested?
Revision Total Knee Arthroplasty
Type of treatment
Surgery or procedure
How many people
30 participants
Where
1 siteCanada
Study dates
21 Aug 2025to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients at University Hospital scheduled to undergo a revision TKA.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brent Lanting, MD, MSc, FRCSC contact

519-685-8500 ext. 33335

Brent.Lanting@lhsc.on.ca

Lyndsay Somerville, PhD contact

519-685-8500 ext. 36645

Lyndsay.Somerville@lhsc.on.ca

Canada1 site, 1 recruiting

  • University Hospital

    London, Ontario, N6A5A5

    Lyndsay Somerville, PhD, 519-685-8500 ext. 36645, Lyndsay.Somerville@lhsc.on.ca

    Brent Lanting, MD, MSc, FRCSC

    Recruiting

Other trials in Canada

About this study

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

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.

Being tested
Revision Total Knee Arthroplasty
Keywords
Revision TKA, Gut Microbiome, Implant Loosening, Inflammation, Weight-Bearing Computed Tomography, PET/CT
Medical subject headings
Osteoarthritis, Knee, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Revision Total Knee ArthroplastyProcedure or surgery

    Study participants must be scheduled to receive a revision TKA.

Study groups in NCT06951477
Study groupRoleWhat they receive
Revision TKAParticipants 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.
Receives: Procedure: Revision Total Knee Arthroplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Gut Microbiome Composition

    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.

    Measured: 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 (2)

  1. Inducible Displacement Measurements with Weight-Bearing Computed Tomography (WBCT)

    Seated and standing WBCT exams will be performed. The bone and implant will be segmented, and a novel software (WBCT-based radiostereometric analysis (WBCT-RSA)) will be used to measure implant motion between the double seated exams (precision) or seated and standing exams (inducible displacement). Change in implant position will be measured in millimeters as maximum total point motion (MTPM). MTPM will be compared between the revision TKA cohort and a cohort with well-functioning implants.

    Measured: WBCT exams will be performed at one timepoint prior to the study participant's revision surgery.

  2. Inflammation in the Knee Joint Based on [18F]FEPPA Standard Uptake Values (SUV)

    Positron Emission Tomography/Computed Tomography (PET/CT) of the knee joint will be performed using the radiotracer [18F]FEPPA, which binds to molecules highly expressed on inflammatory cells. Radiotracer uptake will be quantified using SUV. SUV near the bone and joint will be calculated and compared between the revision TKA cohort and the well-functioning TKA cohort.

    Measured: PET/CT exams will be performed at one timepoint prior to the study participant's revision surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2025
  2. Study start21 Aug 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06951477
Sponsor's protocol ID
126857
Acronym
GUMBO
Status last verified
Sep 2026
First submitted
7 Apr 2025
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35106346

  • Chisari E, Wouthuyzen-Bakker M, Friedrich AW, Parvizi J. The relation between the gut microbiome and osteoarthritis: A systematic review of literature. PLoS One. 2021 Dec 16;16(12):e0261353. doi: 10.1371/journal.pone.0261353. eCollection 2021.

    PubMed 34914764

  • Hernandez CJ. Musculoskeletal microbiology: The utility of the microbiome in orthopedics. J Orthop Res. 2021 Feb;39(2):251-257. doi: 10.1002/jor.24927. Epub 2020 Dec 7.

    PubMed 33245146

  • Boer CG, Radjabzadeh D, Medina-Gomez C, Garmaeva S, Schiphof D, Arp P, Koet T, Kurilshikov A, Fu J, Ikram MA, Bierma-Zeinstra S, Uitterlinden AG, Kraaij R, Zhernakova A, van Meurs JBJ. Intestinal microbiome composition and its relation to joint pain and inflammation. Nat Commun. 2019 Oct 25;10(1):4881. doi: 10.1038/s41467-019-12873-4.

    PubMed 31653850

  • Moran MM, Wilson BM, Li J, Engen PA, Naqib A, Green SJ, Virdi AS, Plaas A, Forsyth CB, Keshavarzian A, Sumner DR. The gut microbiota may be a novel pathogenic mechanism in loosening of orthopedic implants in rats. FASEB J. 2020 Nov;34(11):14302-14317. doi: 10.1096/fj.202001364R. Epub 2020 Sep 15.

    PubMed 32931052

  • Bourdon CE, Koudys ZJ, Lanting BA, Appleton CT, Thiessen JD, Teeter MG. Attenuation correction for PET/MRI to measure tracer activity surrounding total knee arthroplasty. Eur J Hybrid Imaging. 2022 Nov 7;6(1):31. doi: 10.1186/s41824-022-00152-3.

    PubMed 36336748

Questions about this trial

What is this clinical trial studying?

An observational study of Revision Total Knee Arthroplasty and Osteoarthritis, Knee, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brent Lanting, MD, MSc, FRCSC (519-685-8500 ext. 33335, Brent.Lanting@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gut Microbiome Composition (time frame: Gut microbiome composition will be assessed pre-operatively and at 5 days and 6 weeks post-operation to determine how it changes post-operation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06951477, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.

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