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

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

NCT Number	NCT06944288
Lead Sponsor	Istituto Clinico Humanitas Collaborators: Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
Conditions	Knee Prosthesis, Knee Prosthesis Infection, Disbiosis
Enrollment	170 participants
Start Date	2026-02-01
Primary Completion	2026-04-01 (estimated)
Study Completion	2026-05-30 (estimated)
Updated on ClinicalTrials.gov	2025-04-25