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Darmmikrobiom in der Orthopädie: Revision Total Knie -Arthroplastik (GUMBO)

Darmmikrobiom in der Orthopädie: Untersuchung der Rolle der Darmmikrobiomzusammensetzung bei Total Knie -Arthroplastikversagen

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.

Studienübersicht

Status

Rekrutierung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

30

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

    • Ontario
      • London, Ontario, Kanada, N6A5A5
        • Rekrutierung
        • University Hospital
        • Kontakt:
        • Hauptermittler:
          • Brent Lanting, MD, MSc, FRCSC

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Patients at University Hospital scheduled to undergo a revision TKA.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: COHORT
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.

Study participants must be scheduled to receive a revision TKA.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Gut Microbiome Composition
Zeitfenster: Gut microbiome composition will be assessed pre-operatively and at 5 days and 6 weeks post-operation to determine how it changes post-operation.

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.

Gut microbiome composition will be assessed pre-operatively and at 5 days and 6 weeks post-operation to determine how it changes post-operation.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Inducible Displacement Measurements with Weight-Bearing Computed Tomography (WBCT)
Zeitfenster: WBCT exams will be performed at one timepoint prior to the study participant's revision surgery.

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.

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

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.

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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Inducible Displacement and Microbiome Composition
Zeitfenster: 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.

Joint and gut microbiome composition, along with inducible displacement measurements, will be assessed to determine whether alterations in the gut microbiome lead to increased within-bone implant motion.

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.
Implant Wear Volume and Within-Bone Implant Motion from Inducible Displacement Exams
Zeitfenster: 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.

Seated and standing WBCT exams will be performed. The bone and implant will be segmented, and a novel software (WBCT-RSA) will be used to measure implant motion between the seated and standing exams (inducible displacement). Change in implant position will be measured in millimeters as MTPM. An optical coordinate measuring machine will be used to quantitatively measure the amount of volume loss from the retrieved implant components. Inducible displacement MTPM will be compared to volume loss to determine if greater within-bone implant motion may cause greater wear of the implant component resulting in more volume loss.

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.
Metal Ion Levels and Within-Bone Implant Motion from Inducible Displacement Exams
Zeitfenster: Inducible displacement exams will be performed pre-operatively and will be compared to the amount of circulating metal ions pre-operation.

Seated and standing WBCT exams will be performed. The bone and implant will be segmented, and a novel software (WBCT-RSA) will be used to measure implant motion between the seated and standing exams (inducible displacement). Change in implant position will be measured in millimeters as MTPM. Metal ion levels (cobalt, chromium, nickel, and titanium) will be measured from a blood draw prior to the revision surgery. Inducible displacement MTPM and metal ion levels will be compared to determine if greater within-bone implant motion causes greater levels of circulating metal ions.

Inducible displacement exams will be performed pre-operatively and will be compared to the amount of circulating metal ions pre-operation.
[18F]FEPPA Activity and Microbiome Composition
Zeitfenster: 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.

Joint and gut microbiome composition will be compared to [18F]FEPPA activity, to assess whether alterations in the gut microbiome contribute to increased inflammation in the knee joint.

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.
[18F]FEPPA Activity and Implant Wear Volume
Zeitfenster: 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.

[18F]FEPPA activity from PET/CT will be used to detect the amount of inflammation present in the knee joint. An optical coordinate measuring machine will be used to quantitatively measure the amount of volume loss from the retrieved implant components as an indicator of wear. The relationship between volume loss and [18F]FEPPA activity will be assessed.

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.
[18F]FEPPA Activity and Metal Ion Levels
Zeitfenster: PET/CT exams will be performed pre-operatively and will be compared to the amount of circulating metal ions pre-operation.

[18F]FEPPA activity from PET/CT will be used to detect the amount of inflammation present in the knee joint. Metal ion levels (cobalt, chromium, nickel, and titanium) will be measured pre-operatively and the relationship between inflammation and circulating metal ions will be assessed.

PET/CT exams will be performed pre-operatively and will be compared to the amount of circulating metal ions pre-operation.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Brent Lanting, MD, MSc, FRCSC, Schulich School of Medicine & Dentistry

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

21. August 2025

Primärer Abschluss (Geschätzt)

1. Dezember 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

7. April 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. April 2025

Zuerst gepostet (Tatsächlich)

30. April 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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