OsteoarthritisSYNPANCT07473414
Synovial Tissue as a Biomarker in the Early Management of Osteoarthritis
A study testing synovial biopsies in people with Osteoarthritis, run by Nantes University Hospital at 2 sites in France.
Trial summary
Osteoarthritis is a common disease whose prevalence continues to increase. To date, there is no medical treatment that has proven effective, and only symptomatic treatments exist, mainly to reduce pain. Arthroplasty, a costly and invasive surgical procedure, is often unavoidable in advanced stages of the disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- synovial biopsies
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 26 May 2026to 26 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of early osteoarthritis defined by the following clinical criteria:
- score ≤ 85% in at least two of the four categories of the KOOS questionnaire: pain, symptoms/signs, function and quality of life;
- presence of tenderness on palpation of the joint space or crepitus (clinical examination);
- Kellgren and Lawrence (KL) score of 0 or 3 (X-rays).
- Referred for therapeutic management including an intra-articular injection in the affected knee
- Patient affiliated with a social security scheme
- Patient able to understand the protocol and having signed an informed consent form.
Who cannot join
- Minors
- Adults under guardianship or trusteeship
- Pregnant women
- Breastfeeding women
- Protected patients
- Curative anticoagulation
- Thrombocytopenia < 50,000 platelets/mm3
- Patients who object to participating in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU de Nantes
Nantes, 44000
Benoit Le Goff, +33 2 40 08 48 25, benoit.legoff@chu-nantes.fr
- Recruiting
CHU de Nantes
Nantes, 44093
Benoît LE GOFF, 0240084825, benoit.legoff@chu-nantes.fr
About this study
Osteoarthritis is a common disease whose prevalence continues to increase. To date, there is no medical treatment that has proven effective, and only symptomatic treatments exist, mainly to reduce pain.
Arthroplasty, a costly and invasive surgical procedure, is often unavoidable in advanced stages of the disease. More than just a degenerative disease of the cartilage, osteoarthritis is now recognised as a heterogeneous disease causing multi-tissue damage of varying intensity. Synovitis plays a particularly important role in the onset and progression of osteoarthritis and has been closely correlated with radiographic severity, pain and loss of joint function. The investigators have identified several synovial histological pathotypes based on the type of synovial cell infiltrate and its distribution in samples from advanced osteoarthritis (surgical waste from prosthesis implantation). The investiogators' studies show that the presence of these pathotypes appears to be related to the clinical phenotype of patients. Analysis of synovial tissue at earlier stages of the disease is now essential to advance the understanding of the role of synovitis in osteoarthritis and its link to the clinical phenotype of patients.
The objective of this protocol is to describe the different synovial histological pathotypes present in the early stages of osteoarthritis; To this end, the investigators will establish a cohort of osteoarthritis patients with a collection of synovial tissue samples obtained by ultrasound-guided needle biopsy in an outpatient setting, a well-tolerated procedure with simple follow-up, as well as blood sampling.
Read the detailed description
Osteoarthritis is a common disease whose prevalence continues to increase. It results from a variety of factors, such as ageing, excess weight and trauma, for example. To date, there is no medical treatment that has proven effective, and only symptomatic treatments exist, mainly to reduce pain. Arthroplasty, a costly and invasive surgical procedure, is often unavoidable in the advanced stages of the disease. More than just a degenerative disease of the cartilage, osteoarthritis is now recognised as a heterogeneous disease causing multi-tissue damage of varying intensity. Synovitis plays an important role in the initiation and progression of osteoarthritis and has been closely correlated with radiographic severity, pain and loss of joint function. The investigators have identified several synovial histological pathotypes based on the type of synovial cell infiltrate and its distribution in samples of advanced osteoarthritis (surgical waste from prosthesis implantation). The investigators' studies show that the presence of these pathotypes appears to be linked to the clinical phenotype of patients. Analysis of synovial tissue at earlier stages of the disease is now essential to advance our understanding of the role of synovitis in osteoarthritis and its link to the clinical phenotype of patients. The aim of this protocol is to describe the different synovial histological pathotypes present in the early stages of osteoarthritis; To this end, the investigators will establish a cohort of osteoarthritis patients and collect synovial tissue samples via ultrasound-guided needle biopsy in an outpatient setting, a well-tolerated procedure with simple after-effects, as well as blood samples. This procedure will be performed during an intra-articular injection scheduled as part of the patient's treatment. These samples will be used as part of a translational research project funded by the French National Research Agency (ANR). Patients' clinical data will be collected prospectively as part of a cohort study, including clinical and radiographic assessment of osteoarthritis. The objective of the study is to better understand the pathophysiological mechanisms governing the development of osteoarthritis within the synovial membrane in the early stages of the disease, thereby improving its management, identifying new therapeutic targets and paving the way for personalised medicine for patients suffering from osteoarthritis.
- Conditions
- Osteoarthritis
- Being tested
- synovial biopsies
- Keywords
- arthroplasty, synovial tissue, synovial histological pathotypes
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synovial biopsiesOther
The procedure for performing ultrasound-guided synovial biopsies is as follows:
- This is performed under local anaesthetic, in the consultation room, under strict aseptic conditions in five stages.
- After tracing anaesthesia up to the capsule, 2 to 3 mL of lidocaine are injected intra-articularly.
- A 13G coaxial needle is then positioned in the joint cavity, allowing multiple biopsies to be performed without causing tissue damage along the needle path.
- Samples are taken using a 14G semi-automatic Tru-Cut with a notch allowing the collection of 1 mm x 2 cm synovial samples. The aim is to perform histological, immunohistochemical, cell culture and high-throughput analyses. Ideally, 6 to 12 additional biopsies will be performed for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| Biopsy group | Other | Not described Receives: Other: synovial biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
describe the different synovial histological pathotypes
describe the different synovial histological pathotypes present in the early stages of osteoarthritis. To this end, we will establish a cohort and a bio-collection of synovial tissue and blood samples (peripheral blood mononuclear cells, PBMC, serum) from patients with early osteoarthritis.
Measured: During visit inclusion
Secondary outcomes (8)
Histological analyses of tissue to validate its quality
Histological analyses of tissue to validate its quality
Measured: during visit inclusion
Biopsy tolerance
Pain score [0 to 10] reported by the patient to assess the pain experienced during the procedure . 10 being the worst and 0 being the best (no pain).
Collection of immediate complications (bleeding, vasovagal episodes, Pain score [0 to 10] after the biopsy procedure) .
Measured: during visit inclusion
Patient acceptability of samples
The following question will be asked on Day 15: Would you be willing to repeat this procedure if necessary?
Measured: on the 15th day
Histological analyses to quantify synovial inflammatory infiltrate
Measured: During visit inclusion
Analyses of the relationship between the extent and quality of cellular infiltration in histology and the intensity of synovitis determined by ultrasound
Measured: During visit inclusion
High-throughput tissue analysis (single-cell sequencing, spatial transcriptomics)
Measured: During visit inclusion
Effect of in vitro and ex vivo immune cell modulation strategies on synovial membrane explants
Measured: On the 15th day
Analysis of the relationship between circulating and synovial immune populations
Measured: During visit inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start26 May 2026
- Primary completion26 May 2027 (estimated)
- Study completion26 May 2028 (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 Nantes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473414
- Sponsor's protocol ID
- RC25_0342
- Acronym
- SYNPA
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synovial Tissue as a Biomarker in the Early Management of Osteoarthritis
- ClinicalTrials.gov ID
- NCT07473414
- Acronym / sponsor ID
- SYNPA / RC25_0342
- Conditions
- Osteoarthritis
- Keywords
- arthroplasty, synovial tissue, synovial histological pathotypes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 26 May 2026 (actual)
- Primary completion
- 26 May 2027 (estimated)
- Study completion
- 26 May 2028 (estimated)
- First posted
- 16 Mar 2026 (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 is a common disease whose prevalence continues to increase. To date, there is no medical treatment that has proven effective, and only symptomatic treatments exist, mainly to reduce pain.
Arthroplasty, a costly and invasive surgical procedure, is often unavoidable in advanced stages of the disease. More than just a degenerative disease of the cartilage, osteoarthritis is now recognised as a heterogeneous disease causing multi-tissue damage of varying intensity. Synovitis plays a particularly important role in the onset and progression of osteoarthritis and has been closely correlated with radiographic severity, pain and loss of joint function. The investigators have identified several synovial histological pathotypes based on the type of synovial cell infiltrate and its distribution in samples from advanced osteoarthritis (surgical waste from prosthesis implantation). The investiogators' studies show that the presence of these pathotypes appears to be related to the clinical phenotype of patients. Analysis of synovial tissue at earlier stages of the disease is now essential to advance the understanding of the role of synovitis in osteoarthritis and its link to the clinical phenotype of patients.
The objective of this protocol is to describe the different synovial histological pathotypes present in the early stages of osteoarthritis; To this end, the investigators will establish a cohort of osteoarthritis patients with a collection of synovial tissue samples obtained by ultrasound-guided needle biopsy in an outpatient setting, a well-tolerated procedure with simple follow-up, as well as blood sampling.
Detailed description
Osteoarthritis is a common disease whose prevalence continues to increase. It results from a variety of factors, such as ageing, excess weight and trauma, for example. To date, there is no medical treatment that has proven effective, and only symptomatic treatments exist, mainly to reduce pain. Arthroplasty, a costly and invasive surgical procedure, is often unavoidable in the advanced stages of the disease. More than just a degenerative disease of the cartilage, osteoarthritis is now recognised as a heterogeneous disease causing multi-tissue damage of varying intensity. Synovitis plays an important role in the initiation and progression of osteoarthritis and has been closely correlated with radiographic severity, pain and loss of joint function. The investigators have identified several synovial histological pathotypes based on the type of synovial cell infiltrate and its distribution in samples of advanced osteoarthritis (surgical waste from prosthesis implantation). The investigators' studies show that the presence of these pathotypes appears to be linked to the clinical phenotype of patients. Analysis of synovial tissue at earlier stages of the disease is now essential to advance our understanding of the role of synovitis in osteoarthritis and its link to the clinical phenotype of patients. The aim of this protocol is to describe the different synovial histological pathotypes present in the early stages of osteoarthritis; To this end, the investigators will establish a cohort of osteoarthritis patients and collect synovial tissue samples via ultrasound-guided needle biopsy in an outpatient setting, a well-tolerated procedure with simple after-effects, as well as blood samples. This procedure will be performed during an intra-articular injection scheduled as part of the patient's treatment. These samples will be used as part of a translational research project funded by the French National Research Agency (ANR). Patients' clinical data will be collected prospectively as part of a cohort study, including clinical and radiographic assessment of osteoarthritis. The objective of the study is to better understand the pathophysiological mechanisms governing the development of osteoarthritis within the synovial membrane in the early stages of the disease, thereby improving its management, identifying new therapeutic targets and paving the way for personalised medicine for patients suffering from osteoarthritis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biopsy group | Other | Other: synovial biopsies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of early osteoarthritis defined by the following clinical criteria:
- Referred for therapeutic management including an intra-articular injection in the affected knee
- Patient affiliated with a social security scheme
- Patient able to understand the protocol and having signed an informed consent form.
Key exclusion criteria (8 listed)
- Minors
- Adults under guardianship or trusteeship
- Pregnant women
- Breastfeeding women
- Protected patients
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 biopsiesThe procedure for performing ultrasound-guided synovial biopsies is as follows: * This is performed under local anaesthetic, in the consultation room, under strict aseptic conditions in five stages. * After tracing anaesthesia up to the capsule, 2 to 3 mL of lidocaine are injected intra-articularly. * A 13G coaxial needle is then positioned in the joint cavity, allowing multiple biopsies to be performed without causing tissue damage along the needle path. * Samples are taken using a 14G semi-automatic Tru-Cut with a notch allowing the collection of 1 mm x 2 cm synovial samples. The aim is to perform histological, immunohistochemical, cell culture and high-throughput analyses. Ideally, 6 to 12 additional biopsies will be performed for research purposes. | Other | Biopsy group |
Primary outcome
describe the different synovial histological pathotypes
Time frame: During visit inclusion
describe the different synovial histological pathotypes present in the early stages of osteoarthritis. To this end, we will establish a cohort and a bio-collection of synovial tissue and blood samples (peripheral blood mononuclear cells, PBMC, serum) from patients with early osteoarthritis.
8 secondary outcomes
Histological analyses of tissue to validate its quality
Time frame: during visit inclusion
Biopsy tolerance
Time frame: during visit inclusion
Patient acceptability of samples
Time frame: on the 15th day
Histological analyses to quantify synovial inflammatory infiltrate
Time frame: During visit inclusion
Analyses of the relationship between the extent and quality of cellular infiltration in histology and the intensity of synovitis determined by ultrasound
Time frame: During visit inclusion
High-throughput tissue analysis (single-cell sequencing, spatial transcriptomics)
Time frame: During visit inclusion
Effect of in vitro and ex vivo immune cell modulation strategies on synovial membrane explants
Time frame: On the 15th day
Analysis of the relationship between circulating and synovial immune populations
Time frame: During visit inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing synovial biopsies in people with Osteoarthritis, run by Nantes University Hospital at 2 sites 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 8 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: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benoit Le Goff, Pr (02 40 08 48 25 ext. +33, benoit.legoff@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
describe the different synovial histological pathotypes (time frame: During visit inclusion). 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 25 Jun 2026.