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OpenTrials
Completed

NCT Number: NCT03417167

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

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.

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Key information

Conditions

Arthritis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AP-HP, Paris, Lariboisière, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

US-guided synovial biopsy

Other

Needle Synovial biopsy performed using a Tru-cut® device.

Primary outcomes

  1. number of cases where the synovial biopsy allows drawing a definite diagnosis

    Time frame: 10 days

    Final diagnosis will be classified in 5 groups: infectious, crystal induced arthritis, tumoral, inflammatory rheumatisms, others (amyloidosis etc …)

Secondary outcomes

  1. Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

"Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series"

Acronym: BIOPSYN

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 31, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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