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Microbiome intestinal en orthopédie: révision de l'arthroplastie totale du genou (GUMBO)

Microbiome intestinal en orthopédie: étudier le rôle de la composition du microbiome intestinal dans une défaillance totale d'arthroplastie du genou

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.

Aperçu de l'étude

Type d'étude

Observationnel

Inscription (Estimé)

30

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Ontario
      • London, Ontario, Canada, N6A5A5
        • Recrutement
        • University Hospital
        • Contact:
        • Chercheur principal:
          • Brent Lanting, MD, MSc, FRCSC

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

Patients at University Hospital scheduled to undergo a revision TKA.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Gut Microbiome Composition
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Inducible Displacement Measurements with Weight-Bearing Computed Tomography (WBCT)
Délai: 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)
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Inducible Displacement and Microbiome Composition
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

21 août 2025

Achèvement primaire (Estimé)

1 décembre 2027

Achèvement de l'étude (Estimé)

1 décembre 2027

Dates d'inscription aux études

Première soumission

7 avril 2025

Première soumission répondant aux critères de contrôle qualité

22 avril 2025

Première publication (Réel)

30 avril 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

17 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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