Synovial Tissue as a Biomarker in the Early Management of Osteoarthritis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • synovial biopsies

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Biopsy groupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During visit inclusion

Secondary outcomes

1

Histological analyses of tissue to validate its quality

Histological analyses of tissue to validate its quality

Time frame
during visit inclusion
2

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) .

Time frame
during visit inclusion
3

Patient acceptability of samples

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

Time frame
on the 15th day
4

Histological analyses to quantify synovial inflammatory infiltrate

Time frame
During visit inclusion

Other outcomes

Sponsors and contacts

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