OsteoarthritisMOTEMNCT03347500
Microfluidic Organotypic Model for Monocyte Transendothelial Migration to the Joint in Obese Osteoarthritic Patients
An observational study of Osteoarthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial summary
Osteoarthritis (OA) is the fastest growing cause of disability worldwide due to population ageing and increasing obesity incidence. Obese individuals have a higher risk of OA insurgence and severe progression due to several risk factors, including their systemic inflammation state and superior migratory ability of… Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- use of patient-derived biological samples
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Dec 2017to Jul 2019
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: OA patients undergoing prosthetic surgery at IRCCS Istituto Ortopedico Galeazzi
Who may be able to join
- Obese OA patients
- Subscription of informed consent
- BMI ≥ 30
- age between 60-80 years included
- Kelgrenn-Lawrence equal or superior to grade III
- presence of synovitis
Show all 16Show fewer
- patients undergoing knee replacement
- suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice
- Non-obese OA patients
- Subscription of informed consent
- BMI ≤ 28
- age between 60-80 years included
- Kelgrenn-Lawrence equal or superior to grade III
- presence of synovitis
- patients undergoing knee replacement
- suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice
Who cannot join
- Obese OA patients - HCV, HIV, HBV, TPHA infection
- Non-obese OA patients
- HCV, HIV, HBV, TPHA infection
About this study
Official title: Development of a Microfluidic Organotypic Model to Evaluate Monocyte Transendothelial Migration to the Joint in Obese Osteoarthritic Patients
Osteoarthritis (OA) is the fastest growing cause of disability worldwide due to population ageing and increasing obesity incidence. Obese individuals have a higher risk of OA insurgence and severe progression due to several risk factors, including their systemic inflammation state and superior migratory ability of monocytes. In the present project we aim at the development of a novel 3D microfluidic organotypic model resembling the joint to investigate the migration ability of monocytes from obese and non-obese OA patients.
We hypothesize that monocytes from obese OA patients display superior migration ability and a specific pattern of chemokine surface receptors compared to monocytes from non-obese OA patients. We also hypothesize that these features lead to a superior infiltration of monocytes/macrophages to the synovial membrane in obese OA patients. Based on this, our main aim will be to highlight differences between Mo from obese and non-obese OA patients in terms of surface receptors and migration ability in a microfluidic organotypic model.
- Conditions
- Osteoarthritis
- Being tested
- use of patient-derived biological samples
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of patient-derived biological samplesOther
We will use biological samples that are routinely collected as waste material from patients undergoing prosthetic surgery at IRCCS Istituto Ortopedico Galeazzi. Peripheral blood will be also collected from patients during the pre-surgery visit and during the post-surgery hospitalization coinciding with routine blood sample collection.
| Study group | Role | What they receive |
|---|---|---|
| obese OA patients | Use of patient-derived biological samples
Inclusion Criteria:
* Subscription of informed consent
* BMI ≥ 30
* age between 60-80 years included
* Kelgrenn-Lawrence equal or superior to grade III
* presence of synovitis
* patients undergoing knee replacement
* suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice
Exclusion criteria:
- HCV, HIV, HBV, TPHA infection Receives: Other: use of patient-derived biological samples | |
| Non-obese OA patients | Use of patient-derived biological samples
Inclusion criteria:
* Subscription of informed consent
* BMI ≤ 28
* age between 60-80 years included
* Kelgrenn-Lawrence equal or superior to grade III
* presence of synovitis
* patients undergoing knee replacement
* suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice
Exclusion criteria:
- HCV, HIV, HBV, TPHA infection Receives: Other: use of patient-derived biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chemokine receptor expression
To evaluate and compare the expression of chemokine surface receptors on monocytes from obese and non-obese OA patients.
Measured: 24 hours
Secondary outcomes (1)
Monocyte transendothelial migration
To monitor the transendothelial migration of monocytes from OA patients in response to chemokines present in the synovial fluid using a microfluidic organotypic model.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347500
- Sponsor's protocol ID
- MOTEM
- Acronym
- MOTEM
- Status last verified
- Nov 2017
- First submitted
- 15 Nov 2017
- Last updated
- 20 Nov 2017
- 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 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Microfluidic Organotypic Model to Evaluate Monocyte Transendothelial Migration to the Joint in Obese Osteoarthritic Patients
- ClinicalTrials.gov ID
- NCT03347500
- Acronym / sponsor ID
- MOTEM / MOTEM
- Conditions
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 20 Nov 2017 (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.
Osteoarthritis (OA) is the fastest growing cause of disability worldwide due to population ageing and increasing obesity incidence. Obese individuals have a higher risk of OA insurgence and severe progression due to several risk factors, including their systemic inflammation state and superior migratory ability of monocytes. In the present project we aim at the development of a novel 3D microfluidic organotypic model resembling the joint to investigate the migration ability of monocytes from obese and non-obese OA patients.
We hypothesize that monocytes from obese OA patients display superior migration ability and a specific pattern of chemokine surface receptors compared to monocytes from non-obese OA patients. We also hypothesize that these features lead to a superior infiltration of monocytes/macrophages to the synovial membrane in obese OA patients. Based on this, our main aim will be to highlight differences between Mo from obese and non-obese OA patients in terms of surface receptors and migration ability in a microfluidic organotypic model.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese OA patients | – | Other: use of patient-derived biological samplesUse of patient-derived biological samples Inclusion Criteria: * Subscription of informed consent * BMI ≥ 30 * age between 60-80 years included * Kelgrenn-Lawrence equal or superior to grade III * presence of synovitis * patients undergoing knee replacement * suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Exclusion criteria: - HCV, HIV, HBV, TPHA infection |
| Non-obese OA patients | – | Other: use of patient-derived biological samplesUse of patient-derived biological samples Inclusion criteria: * Subscription of informed consent * BMI ≤ 28 * age between 60-80 years included * Kelgrenn-Lawrence equal or superior to grade III * presence of synovitis * patients undergoing knee replacement * suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Exclusion criteria: - HCV, HIV, HBV, TPHA infection |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- OA patients undergoing prosthetic surgery at IRCCS Istituto Ortopedico Galeazzi
Key inclusion criteria (16 listed)
- Obese OA patients
- Subscription of informed consent
- BMI ≥ 30
- age between 60-80 years included
- Kelgrenn-Lawrence equal or superior to grade III
Key exclusion criteria (3 listed)
- Obese OA patients - HCV, HIV, HBV, TPHA infection
- Non-obese OA patients
- HCV, HIV, HBV, TPHA infection
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 |
|---|---|---|
| use of patient-derived biological samplesWe will use biological samples that are routinely collected as waste material from patients undergoing prosthetic surgery at IRCCS Istituto Ortopedico Galeazzi. Peripheral blood will be also collected from patients during the pre-surgery visit and during the post-surgery hospitalization coinciding with routine blood sample collection. | Other | Non-obese OA patients, obese OA patients |
Primary outcome
Chemokine receptor expression
Time frame: 24 hours
To evaluate and compare the expression of chemokine surface receptors on monocytes from obese and non-obese OA patients.
1 secondary outcome
Monocyte transendothelial migration
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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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, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
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 16 inclusion and 3 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 20 Nov 2017. 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?
Chemokine receptor expression (time frame: 24 hours). 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 20 Nov 2017; AzTrials last refreshed its copy on 5 Nov 2026.