Indications and Interest of US-guided Synovial Biopsies Performed in Clinical Practice

Completed

• Conditions: Arthritis

• Registration Number: NCT03417167
• Lead Sponsor: Nantes University Hospital

Brief Summary

Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.

Detailed Description

In this study, the investigators will collect all the synovial biopsies performed in clinical practice in 18 Rheumatology Unit throughout France. All the participants received a standardized training on US-guided synovial biopsies. For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form. The investigator will determine the number of cases where the synovial biopsy allows drawing a definite diagnosis.

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-02-14
• Primary Completion: 2020-09-11
• Study Completion: 2020-09-11
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

All patients undergoing an US-guided synovial biopsy in clinical practice in the context of an arthritis of unknown origin

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of cases where the synovial biopsy allows drawing a definite diagnosis	10 days	Final diagnosis will be classified in 5 groups: infectious, crystal induced arthritis, tumoral, inflammatory rheumatisms, others (amyloidosis etc ...)

Secondary Outcome Measures

Name	Time	Method
Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology	1 month	For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form.

Trial Locations

Locations (15)

CHU de Nancy; 🇫🇷 Nancy, France

Chu d'Angers; 🇫🇷 Angers, France

Chu de Dijon; 🇫🇷 Dijon, France

AP-HP; 🇫🇷 Paris, Salpétrière, France

CHU de Poitiers; 🇫🇷 Poitiers, France

CHU CAEN; 🇫🇷 Caen, France

CHD La Roche-sur-Yon; 🇫🇷 La Roche-sur-Yon, France

Chu de Strasbourg; 🇫🇷 Strasbourg, France

Chu de Montpellier; 🇫🇷 Montpellier, France

CHU de Nice; 🇫🇷 Nice, France

Chu de Toulouse; 🇫🇷 Toulouse, France

Chu de Rennes; 🇫🇷 Rennes, France

Chu Brest; 🇫🇷 Brest, France

CHU de Bordeaux; 🇫🇷 Bordeaux, France

AP-HM; 🇫🇷 Marseille, France