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Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination

NCT06944288 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-04-25

No results posted yet for this study

Summary

The patient(s) will participate in a clinical study that aims to investigate how the gut microbiota may influence the proper functioning of joints in the body and how it may affect the development of early osteoarthritis (OA), periprosthetic joint infection (PJI), and recovery after total joint replacement.

In particular, the prevalence of early OA among patients with gut dysbiosis will be studied (Objective 1). The aim is to identify gut dysbiosis as a potential diagnostic factor for early OA. The study will analyze knee MRI scans and shoulder ultrasound images of 40 patients without musculoskeletal symptoms but with confirmed gut dysbiosis.In addition, the intra-articular microbiota in 50 patients undergoing total knee replacement will be investigated. Serum LPS levels during surgery and fecal microbiota before surgery and during postoperative recovery will be assessed (Objective 2). Postoperative recovery will be assessed based on criteria such as time off crutches and subjective scores.

Finally, this will explore the correlation between gut microbiota and contaminating germs in periprosthetic infections. (Objective 3). 40 patients undergoing joint revision surgery for septic failure of a knee or hip replacement and 40 patients undergoing revision surgery for aseptic loosening for PJI will undergo gut microbiota analysis. Comparison between the two groups will allow evaluation of whether PJI causes changes in the gut microbiota.

The patients will be included in the study under

* objective 1
* objective 2
* objective 3

Conditions

  • Knee Prosthesis
  • Knee Prosthesis Infection
  • Disbiosis

Interventions

PROCEDURE

total knee replacement

The Orthopedic Surgeon will remove the damaged cartilage and bone then implant the new metal and plastic knee to restore the alignment and function of your knee. The surgical procedure takes about 1-2 hours on average. While in case of infection, an antibiotic cement is inserted, which will be removed with the subsequent prosthetic implant surgery. Finally, prosthetic components can be more filling, depending on the amount of bone that is previously removed.

Sponsors & Collaborators

  • Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli

    collaborator OTHER

  • Istituto Clinico Humanitas

    lead OTHER

Principal Investigators

  • TOMMASO BONANZINGA · Humanitas Research Hospital IRCCS, Rozzano-Milan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2026-04-01
Completion
2026-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06944288 on ClinicalTrials.gov