Synovial Tissue as a Biomarker in the Early Management of Osteoarthritis

NCT07473414 | Not Yet Recruiting

• 1 other identifier: RC25_0342
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Osteoarthritis

Keywords

arthroplasty; synovial tissue; synovial histological pathotypes

Outcome Measures

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.

  During visit inclusion

Secondary Outcomes (8)

• Histological analyses of tissue to validate its quality

  during visit inclusion

• Biopsy tolerance

  during visit inclusion

• Patient acceptability of samples

  on the 15th day

• Histological analyses to quantify synovial inflammatory infiltrate

  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

  During visit inclusion

Study Arms (1)

Biopsy group

OTHER

Other: synovial biopsies

Interventions

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.

Biopsy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Benoit Le Goff, Pr

CONTACT

02 40 08 48 25; benoit.legoff@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 16, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 16, 2027
• Study Completion (Estimated): April 16, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share