Status:
NOT_YET_RECRUITING
Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Azienda Ospedaliera di Rilievo Nazionale A.Cardarelli
Conditions:
Knee Prosthesis
Knee Prosthesis Infection
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 ...
Detailed Description
The study is a multicentre observational study divided into 3 objectives: Objective #1 is to enrol 40 patients with established intestinal dysbiosis and no musculoskeletal symptoms. Patients with pot...
Eligibility Criteria
Inclusion
- proven gut dysbiosis (increased Firmicutes/Bacteroidetes (F/B) phyla ratio and increased permeability); age range 18-50 years old.
- patients undergoing total knee replacement surgery
- patients undergoing joint revision surgery for septic failure of a knee or hip prostheses; patients undergoing revision surgery for aseptic mobilization for PJI
Exclusion
- musculoskeletal symptoms; previous shoulder or knee surgery; previous shoulder or knee known pathological conditions; rheumatological diseases
- any concurrent or previous diseases or conditions which might negatively affect the surgery
- major predisposing factor for gut dysbiosis (antibiotic therapy in the last 6 months, BMI \> 40 and inflammatory bowel disease); chronic inflammatory joint diseases (e.g., rheumatoid arthritis, psoriatic arthritis); acute (\< 90 days after the index procedure) and late hematogenous (symptoms of less than three weeks duration) infections; an inadequate amount of synovial fluid (\< 10 mL) for culture, WBC, and PMN (neutrophil) percentage determinations
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06944288
Start Date
February 1 2026
End Date
May 30 2026
Last Update
April 25 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.