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NCT Number: NCT07473414

Synovial Tissue as a Biomarker in the Early Management of Osteoarthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes, Nantes, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

synovial biopsies

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Histological analyses of tissue to validate its quality

    Time frame: during visit inclusion

    Histological analyses of tissue to validate its quality

  2. Biopsy tolerance

    Time frame: during visit inclusion

    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) .

  3. Patient acceptability of samples

    Time frame: on the 15th day

    The following question will be asked on Day 15: Would you be willing to repeat this procedure if necessary?

  4. Histological analyses to quantify synovial inflammatory infiltrate

    Time frame: During visit inclusion

  5. 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

  6. High-throughput tissue analysis (single-cell sequencing, spatial transcriptomics)

    Time frame: During visit inclusion

  7. Effect of in vitro and ex vivo immune cell modulation strategies on synovial membrane explants

    Time frame: On the 15th day

  8. Analysis of the relationship between circulating and synovial immune populations

    Time frame: During visit inclusion

Study contacts

Contact information is provided by the study sponsor or research team.

Benoit Le Goff, Pr

CONTACT

[email protected]

02 40 08 48 25 ext. +33

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: SYNPA

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 16, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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