Osteoarthritis, KneeMEDADIPONCT03678831
Characteristics of Marrow Fatty Cells in the Ageing of Bone and Joints, Osteoarthritis and Osteoporosis
An observational study of Osteoarthritis, Knee and Prosthesis User, run by University Hospital, Lille at 1 site in France.
Trial summary
Obesity and other associated complications promote the development and the progression of osteoarthritis. The subcutaneous and abdominal fat release several factors that alter bone and the cartilage. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Osteoarthritis, Knee, Prosthesis User
- What is being tested?
- tissue
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jun 2020to 11 Mar 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Arthritic post-menopausal patients with knee prosthetic replacement
Who may be able to join
- Post-menopausal woman
- with a symptomatic knee osteoarthritis requiring prosthesis
- able to handle general anaesthesia
- having given her consent
- able to understand the constraints associated with the study
- with health insurance
- able to understand the French language
Who cannot join
- with refusal to participate to the study
- more than 85-year-old
- with bone pathologies other than osteoarthritis or osteoporosis
- with active infection
- with evolving cancer
- with haematopoietic pathologies such as haemoglobin pathologies
Show all 14Show fewer
- with thyroid pathologies
- with type 1 diabetes
- with anti-osteoporotic treatments (bisphosphonates, strontium ranelate, teriparatide, denosumab) except calcium and vitamin D supplementation or hormone replacement.
- with replacement of prosthesis
- with previous surgery at the surgery site
- --with a current participation to another study
- with guardianship
- with deprived liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Bone Marrow Adipocytes in Osteoarthritic and Post-menopausal Patients: a Comparative Study With Adipocytes From Subcutaneous Adipose Tissue
Obesity and other associated complications promote the development and the progression of osteoarthritis. The subcutaneous and abdominal fat release several factors that alter bone and the cartilage. The role of the marrow fat in close connection with bone has not been defined yet, whereas cellular and animal models indicate that this fat depot modifies bone and cartilage.
The aim of the study is to define if the marrow fat produces more joint-altering factors by comparison with subcutaneous fat. This fat depot can be characterized from removed pieces during the prosthetic surgery of the knee. Measuring before surgery the body weight, waist and hip circumferences, blood pressure, glucose, insulin and lipids in blood will also allow to determine if obesity and/or type 2 diabetes make this fat more dangerous for the joint. Such research will allow the elaboration of new therapeutic strategies in osteoarthritis.
- Conditions
- Osteoarthritis, Knee, Prosthesis User
- Being tested
- tissue
- Keywords
- Osteoarthritis, prosthetic surgery of the knee, obesity, type 2 diabetes, bone marrow fat
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissueProcedure or surgery
Adipocyte isolation from distal femoral epiphysis and subcutaneous adipose tissue at the surgery site; classical piece removal during prosthetic replacement of the knee
| Study group | Role | What they receive |
|---|---|---|
| Arthritic patients with knee prosthetic replace | Arthritic post-menopausal patients with knee prosthetic replacement Each patient is her own control since the two cell types are compared within the same patient The main criteria is based on a comparison of two cell types from the same patient. The secondary criteria are based on a comparison of cell types according to a grouping of patients according to different metabolic parameters. Receives: Procedure: tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression levels in femoral spinal adipocytes of mRNAs of 18 genes compared to those of adipocytes isolated from the subcutaneous adipose tissue in the same patient
Measured: at 3 months
Secondary outcomes (5)
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Obesity state (normal vs overweight vs obese) as defined using BMI
Measured: at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Central obesity (yes or no) as defined using the waist-to-hip ratio
Measured: at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Presence or absence of systemic insulin-resistance as measured using the HOMA-IR index
the Homeostatic Model Assessment of Insulin Resistance(HOMA-IR index)Healthy Range: 1.0 (0.5-1.4) Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Measured: at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytesaccording to Presence or absence of chronic uncontrolled hyperglycaemia as measured using HbA1c plasma levels
Measured: at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to presence or absence of metabolic syndrome
metabolic syndrome as defined by the presence of at least three of the following criteria: large waist circumference, decrease in HDL-cholesterol, hypertriglyceridemia, elevated fasting glycaemia, elevated blood pressure.
Measured: at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start30 Jun 2020
- Primary completion11 Mar 2024
- Study completion11 Mar 2024
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.
- More trials run by University Hospital, LilleThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- MSDAVENIR Foundation
- Responsible party
- Sponsor
- Investigators
- Gilles Pasquier, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678831
- Sponsor's protocol ID
- 2017_59
- Other IDs
- 2018-A00660-55
- Acronym
- MEDADIPO
- Status last verified
- Dec 2025
- First submitted
- 18 Sep 2018
- Last updated
- 5 Dec 2025
- 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 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Bone Marrow Adipocytes in Osteoarthritic and Post-menopausal Patients: a Comparative Study With Adipocytes From Subcutaneous Adipose Tissue
- ClinicalTrials.gov ID
- NCT03678831
- Acronym / sponsor ID
- MEDADIPO / 2017_59
- Conditions
- Osteoarthritis, Knee, Prosthesis User
- Keywords
- Osteoarthritis, prosthetic surgery of the knee, obesity, type 2 diabetes, bone marrow fat
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- MSDAVENIR Foundation
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 11 Mar 2024 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 20 Sep 2018 (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.
Obesity and other associated complications promote the development and the progression of osteoarthritis. The subcutaneous and abdominal fat release several factors that alter bone and the cartilage. The role of the marrow fat in close connection with bone has not been defined yet, whereas cellular and animal models indicate that this fat depot modifies bone and cartilage.
The aim of the study is to define if the marrow fat produces more joint-altering factors by comparison with subcutaneous fat. This fat depot can be characterized from removed pieces during the prosthetic surgery of the knee. Measuring before surgery the body weight, waist and hip circumferences, blood pressure, glucose, insulin and lipids in blood will also allow to determine if obesity and/or type 2 diabetes make this fat more dangerous for the joint. Such research will allow the elaboration of new therapeutic strategies in osteoarthritis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arthritic patients with knee prosthetic replace | – | Procedure: tissueArthritic post-menopausal patients with knee prosthetic replacement Each patient is her own control since the two cell types are compared within the same patient The main criteria is based on a comparison of two cell types from the same patient. The secondary criteria are based on a comparison of cell types according to a grouping of patients according to different metabolic parameters. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Arthritic post-menopausal patients with knee prosthetic replacement
Key inclusion criteria (7 listed)
- Post-menopausal woman
- with a symptomatic knee osteoarthritis requiring prosthesis
- able to handle general anaesthesia
- having given her consent
- able to understand the constraints associated with the study
Key exclusion criteria (14 listed)
- with refusal to participate to the study
- more than 85-year-old
- with bone pathologies other than osteoarthritis or osteoporosis
- with active infection
- with evolving cancer
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 |
|---|---|---|
| tissueAdipocyte isolation from distal femoral epiphysis and subcutaneous adipose tissue at the surgery site; classical piece removal during prosthetic replacement of the knee | Procedure or surgery | Arthritic patients with knee prosthetic replace |
Primary outcome
Expression levels in femoral spinal adipocytes of mRNAs of 18 genes compared to those of adipocytes isolated from the subcutaneous adipose tissue in the same patient
Time frame: at 3 months
5 secondary outcomes
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Obesity state (normal vs overweight vs obese) as defined using BMI
Time frame: at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Central obesity (yes or no) as defined using the waist-to-hip ratio
Time frame: at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to Presence or absence of systemic insulin-resistance as measured using the HOMA-IR index
Time frame: at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytesaccording to Presence or absence of chronic uncontrolled hyperglycaemia as measured using HbA1c plasma levels
Time frame: at 3 months
the intra patients difference of the expression level of medullary adipocytes mRNA compared to that of subcutaneous adipocytes according to presence or absence of metabolic syndrome
Time frame: at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
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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.
Gilles Pasquier, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Prosthesis User, run by University Hospital, Lille at 1 site in France.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Expression levels in femoral spinal adipocytes of mRNAs of 18 genes compared to those of adipocytes isolated from the subcutaneous adipose tissue in the same patient (time frame: at 3 months). 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 5 Dec 2025.