NCT06527235 Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography
| NCT ID | NCT06527235 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Toulouse |
| Condition | Meniscus Lesion |
| Study Type | INTERVENTIONAL |
| Enrollment | 152 participants |
| Start Date | 2025-03-06 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 152 participants in total. It began in 2025-03-06 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The value of corticosteroid infiltration of the meniscus wall in the therapeutic strategy is not clearly defined: the data in the literature on the effectiveness of corticosteroid infiltration are heterogeneous and of low level of proof. We hypothesize that corticosteroid infiltration of the meniscal wall under ultrasound control would be effective for rapid relief of degenerative meniscal pain. The main objective is to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo, at 1 month, on meniscal pain in the treatment of meniscal pain of degenerative origin in adult.
Eligibility Criteria
Inclusion Criteria: * Localized knee pain with tenderness over the medial or lateral joint space reproduced on clinical examination * Pain assessed with a VAS score \> 4/10 despite first-line medical treatment including the use of tier I or II analgesics or NSAIDs. * An MRI of the knee performed in the 6 months preceding the operation as part of the pre-treatment assessment * Medial or lateral degenerative meniscal lesion on MRI consistent with pain, confirmed by an investigating physician * Affiliation to the Social Security * Free and informed consent signed by the patient Exclusion Criteria: * Patient under curatorship, guardianship or safeguard of justice * Inability to speak, read or write French fluently * Patient deprived of liberty * Patients with psychiatric pathology * Patient who has had an MRI showing an unstable meniscal lesion: complete vertical tear of more than 10 mm in length, capsulomeniscal disinsertion of more than 10 mm in length, complex tear, T2 hypersignal tear of liquid type with passage of liquid testifying to the spreading of the edges, tear with displaced meniscal fragment, lesion of a posterior meniscal brake, lesion of the meniscotibial or meniscofemoral attachment * Patient with an MRI showing recent ligament injury(ies) (cruciate ligaments and/or collateral ligaments) * History of knee trauma less than 3 months * History of arthroscopy or open surgery of the involved knee, * History of corticosteroid injection in the knee concerned in the 3 months preceding inclusion, * Use of NSAIDs and oral corticosteroids during the 48 hours preceding inclusion * Use of tier 3 analgesics for gonalgia in the 3 months prior to inclusion * Episodes of knee instability or true locking * Radiographic gonarthrosis with a Kellgren Lawrence stage \>1 authenticated on radiographic images taken within the last 6 months. * Known inflammatory rheumatism * Fibromyalgia as determined by the clinical investigator * Pregnancy and breastfeeding in progress * Contraindication to the use of injectable corticosteroids: septic arthritis, skin lesions at the injection site, severe coagulation disorders, hypersensitivity to one of the excipients * Contraindication to the use of systemic corticosteroids: acute infection, untreated and uncontrolled chronic infection, psychiatric or ophthalmological pathologies, unbalanced diabetes, uncontrolled hypertension * Contraindication to the use of lidocaine: known hypersensitivity to lidocaine hydrochloride, to local anaesthetics with an amide bond or to one of the excipients, patients with recurrent porphyrias * Patients on anticoagulants
Contact & Investigator
Marie FARUCH, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06527235 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Meniscus Lesion. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06527235 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 152 participants.
Is NCT06527235 currently recruiting?
Yes, NCT06527235 is actively recruiting participants. Contact the research team at faruch.m@chu-toulouse.fr for enrollment information.
Where is the NCT06527235 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT06527235 clinical trial?
NCT06527235 is sponsored by University Hospital, Toulouse. The principal investigator is Marie FARUCH, MD at University Hospital, Toulouse. The trial plans to enroll 152 participants.