Betamethasone dipropionate; Betamethasone sodium phosphate for Degenerative meniscal lesion

Inclusion criteria

• {"criterion_text":"- Patient aged ≥ 18 years\n- Localized knee pain with tenderness over the medial or lateral joint space reproduced on clinical examination\n- Pain assessed with a VAS score > 4/10 despite first-line medical treatment including the use of tier I or II analgesics or NSAIDs\n- An MRI of the knee performed in the 6 months preceding the operation as part of the pre-treatment assessment\n- Medial or lateral degenerative meniscal lesion on MRI consistent with pain, confirmed by an investigating physician\n- Affiliation to the Social Security\n- Free and informed consent signed by the patient"}

Exclusion criteria

• {"criterion_text":"- Patient under 18 years of age\n- History of corticosteroid injection in the knee concerned in the 3 months preceding inclusion\n- Use of NSAIDs and oral corticosteroids during the 48 hours preceding inclusion\n- Use of tier 3 analgesics for gonalgia in the 3 months prior to inclusion\n- Episodes of knee instability or true locking\n- Radiographic gonarthrosis with a Kellgren Lawrence stage > 1 authenticated on radiographic images taken within the last 6 months.\n- Known inflammatory rheumatism\n- Fibromyalgia as determined by the clinical investigator\n- Pregnancy and breastfeeding in progress\n- Contraindication to the use of injectable corticosteroids: septic arthritis, skin lesions at the injection site, severe coagulation disorders, hypersensitivity to one of the excipients\n- Contraindication to the use of systemic corticosteroids: acute infection, untreated and uncontrolled chronic infection, psychiatric or ophthalmological pathologies, unbalanced diabetes, uncontrolled hypertension\n- Patient under curatorship or guardianship\n- 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\n- Patients on anticoagulants\n- Inability to speak, read or write French fluently\n- Patient deprived of liberty\n- Patients with psychiatric pathology\n- 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\n- Patient with an MRI showing recent ligament injury(ies) (cruciate ligaments and/or collateral ligaments)\n- History of knee trauma less than 3 months\n- History of arthroscopy or open surgery of the involved knee"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is the change in meniscal pain measured using the Visual Analog Scale (VAS) between the initial visit and the 1-month follow-up visit","definition_or_measurement_approach":"Change in meniscal pain measured using the Visual Analog Scale (VAS) between baseline (initial visit) and 1-month follow-up"}

Secondary endpoints

• {"endpoint_text":"- the evolution of the VAS score between the initial visit and the 3-month follow-up visit","definition_or_measurement_approach":"Change in VAS score between baseline and 3-month follow-up"}
• {"endpoint_text":"- the evolution of the score of each dimension (Pain, Symptoms, Activities of daily living, Sport and recreation function, and Knee-related qualities of life) of the algo-functional scale KOOS (appendix 1) between the initial visit and the 1-month follow-up visit","definition_or_measurement_approach":"Change in each KOOS dimension score between baseline and 1-month follow-up"}
• {"endpoint_text":"- the evolution of each dimension of the algo-functional scale KOOS score between the initial visit and the 3-month follow-up visit","definition_or_measurement_approach":"Change in each KOOS dimension score between baseline and 3-month follow-up"}
• {"endpoint_text":"- the occurrence of adverse events (AEs) and serious AEs (SAEs) up to 3 months of follow-up","definition_or_measurement_approach":"Recording and reporting of AEs and SAEs occurring up to 3 months after inclusion"}
• {"endpoint_text":"- Analgesic response is defined as a at least 50% reduction in pain (measured using the VAS scale) between the initial visit and the 1-month follow-up visit.","definition_or_measurement_approach":"Analgesic response = ≥50% reduction in VAS score from baseline to 1-month follow-up"}

France

Earliest CTIS Part Ii Submission Date

27-06-2024

Latest Decision Or Authorization Date

13-08-2025

Processing Time Days

412

Number Of Sites

5

Number Of Participants

152

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Toulouse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France