RecruitingPhase 3NCT06527235

Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography

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

Sponsor

University Hospital, Toulouse

Enrollment

152 participants

Start Date

Mar 6, 2025

Study Type

INTERVENTIONAL

Conditions

Meniscus Lesion

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria20

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

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Interventions

DRUGultrasound-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.

DRUGultrasound-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.