About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Minors
Adults under guardianship or trusteeship
Pregnant women
Breastfeeding women
Trial design
Single group
Treatments tested in this trial
synovial biopsies
Other interventionThe 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Histological analyses of tissue to validate its quality
Histological analyses of tissue to validate its quality
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) .
Patient acceptability of samples
The following question will be asked on Day 15: Would you be willing to repeat this procedure if necessary?
Histological analyses to quantify synovial inflammatory infiltrate
Sponsors and contacts
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