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RECRUITING

NCT06527235

PHASE3

Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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.

Official title: Efficacy of Ultrasound-monitored Meniscal Wall Betamethasone Infiltration on Pain in Relation to Degenerative Meniscal Injury: a Randomized, Double-blind, Placebo-controlled Multicenter Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

152

Start Date

2025-03-06

Completion Date

2028-06-01

Last Updated

2025-12-04

Healthy Volunteers

Conditions

Meniscus Lesion

Interventions

DRUG

ultrasound-guided betamethasone infiltration of the meniscal wall

The perimeniscal injections will be guided by ultrasound with an 18 megahertz (MHz) linear probe under strict aseptic conditions. Doppler will be systematically used before the injection to identify the medial or lateral inferior geniculate artery. The first step will consist of local anesthesia with 2 ml of lidocaine injected into the subcutaneous tissues and close to the meniscus wall using a 25-gauge needle. Using an in-plane approach, a 21-gauge needle will be positioned under ultrasound guidance in the medial or lateral wall of the meniscus. Once the needle touches the meniscus wall, it will be withdrawn 1 mm, and a 1-ml injection of betamethasone into the meniscus wall will be performed.

DRUG

ultrasound-guided isotonic saline (placebo) infiltration of the meniscal wall

The perimeniscal injections will be guided by ultrasound with an 18 MHz linear probe under strict aseptic conditions. Doppler will be systematically used before the injection to identify the medial or lateral inferior geniculate artery. The first step will consist of local anesthesia with 2 ml of isotonic saline injected into the subcutaneous tissues and close to the meniscus wall using a 25-gauge needle. Using an in-plane approach, a 21-gauge needle will be positioned under ultrasound guidance in the medial or lateral wall of the meniscus. Once the needle touches the meniscus wall, it will be withdrawn 1 mm, and a 1-ml injection of betamethasone into the meniscus wall will be performed.

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

Locations (1)

UHToulouse

Toulouse, France