Betamethasone meniscal infiltration under ultrasound control: a randomized, double-blind, placebo-controlled multicenter trial.

Phase 1

Active, not recruiting

• Conditions: meniscal pain of degenerative origin; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: CTIS2023-510079-74-00
• Lead Sponsor: Centre Hospitalier Universitaire De Toulouse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-26
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Patient aged = 18 years, 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 3 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 18 years of age, 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, Patient under curatorship or guardianship, 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, 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 confirmed by the coordinating radiologist: 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified