Gut Microbiome in Orthopaedics: Revision Total Knee Arthroplasty

NCT ID: NCT06951477

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-31

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Revision Total Knee Arthroplasty Osteoarthritis, Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Revision TKA

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.

Revision Total Knee Arthroplasty

Intervention Type PROCEDURE

Study participants must be scheduled to receive a revision TKA.

Interventions

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Revision Total Knee Arthroplasty

Study participants must be scheduled to receive a revision TKA.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Brent Lanting

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brent Lanting, MD, MSc, FRCSC

Role: PRINCIPAL_INVESTIGATOR

Schulich School of Medicine & Dentistry

Locations

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University Hospital

London, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Brent Lanting, MD, MSc, FRCSC

Role: CONTACT

519-685-8500 ext. 33335

Lyndsay Somerville, PhD

Role: CONTACT

519-685-8500 ext. 36645

Facility Contacts

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Lyndsay Somerville, PhD

Role: primary

519-685-8500 ext. 36645

References

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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.

Reference Type BACKGROUND
PMID: 39545647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35029750 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33448869 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31283731 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34648464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34151053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34735461 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35106346 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34914764 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33245146 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31653850 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32931052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36336748 (View on PubMed)

Other Identifiers

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126857

Identifier Type: -

Identifier Source: org_study_id

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