Osteoarthritis, KneeNCT05678049
Evaluation and Characterisation of Microplastics and Nanoplastics in Joint Synovial Liquid
An observational study of Osteoarthritis, Knee and Knee Arthritis, run by Iuliu Hatieganu University of Medicine and Pharmacy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee, Knee Arthritis, Gout Arthritis
- What is being tested?
- Synovial fluid analysis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients on a Rehab Department with arthritis of the knee that require evacuation of the knee joint
Who may be able to join
- arthritis of the knee with liquid aspiration recommendation
- age >18 years
Who cannot join
- --refusal of the patient to participate
- -age<18 years
About this study
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.
- Being tested
- Synovial fluid analysis
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Gouty, Elephantiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
microplastics
evaluation with spectrophotometry and optic microscopy
Measured: immediately after liquid extraction
nanoplastics
evaluation with spectrophotometry and optic microscopy
Measured: immediately after liquid extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion15 Dec 2023 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ciubean Alina Deniza, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678049
- Sponsor's protocol ID
- UMFCluj
- Status last verified
- Jan 2023
- First submitted
- 15 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Characterisation of Microplastics and Nanoplastics in Joint Synovial Liquid
- ClinicalTrials.gov ID
- NCT05678049
- Acronym / sponsor ID
- UMFCluj
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 15 Dec 2023 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients on a Rehab Department with arthritis of the knee that require evacuation of the knee joint
Key inclusion criteria (2 listed)
- arthritis of the knee with liquid aspiration recommendation
- age >18 years
Key exclusion criteria (2 listed)
- --refusal of the patient to participate
- -age<18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synovial fluid analysisFor 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 | Diagnostic test | – |
Primary outcome
microplastics
Time frame: immediately after liquid extraction
evaluation with spectrophotometry and optic microscopy
nanoplastics
Time frame: immediately after liquid extraction
evaluation with spectrophotometry and optic microscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Knee Arthritis, run by Iuliu Hatieganu University of Medicine and Pharmacy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microplastics (time frame: immediately after liquid extraction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.