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NOT YET RECRUITING
NCT06944288
NA

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

Sponsor: Istituto Clinico Humanitas

View on ClinicalTrials.gov

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

Official title: Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination (MILESTONE)

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2026-02-01

Completion Date

2026-05-30

Last Updated

2025-04-25

Healthy Volunteers

No

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.