NCT05678049

Brief Summary

The research study aims to evaluate the synovial fluid to highlight the presence of possible micropolymers (micro/nanoplastics) in order to better understand the pathophysiology of joint degenerative processes. For patients with liquid under tension at the joint level, the symptomatology often requires evacuation by puncture under ultrasound guidance. The intervention will be performed only for patients for whom this therapeutic indication exists anyway by their physician. The investigators want to use this liquid for Microscopic and Spectrophotometric evaluation.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

December 15, 2022

Last Update Submit

January 3, 2023

Conditions

Osteoarthritis, KneeKnee ArthritisGout ArthritisMicrocrystal Disease

Outcome Measures

Primary Outcomes (2)

  • microplastics

    evaluation with spectrophotometry and optic microscopy

    immediately after liquid extraction

  • nanoplastics

    evaluation with spectrophotometry and optic microscopy

    immediately after liquid extraction

Interventions

Synovial fluid analysisDIAGNOSTIC_TEST

For patients with knee under tension at the joint level, the symptomatology often requires evacuation by puncture under ultrasound guidance. The intervention will be performed only for patients for whom this therapeutic indication exists anyway by their physicians. After making the evacuation we will want to use this liquid for Microscopic and Spectrophotometric evaluation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients on a Rehab Department with arthritis of the knee that require evacuation of the knee joint

You may qualify if:

  • arthritis of the knee with liquid aspiration recommendation
  • age \>18 years

You may not qualify if:

  • refusal of the patient to participate
  • age\<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis, KneeArthritis, GoutyElephantiasis

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesGoutCrystal ArthropathiesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesLymphedemaLymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

December 15, 2022

First Posted

January 10, 2023

Study Start

January 15, 2023

Primary Completion

December 15, 2023

Study Completion

December 15, 2024

Last Updated

January 10, 2023

Record last verified: 2023-01