Ultrasound-guided betamethasone injection into the meniscal wall

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, placebo-controlled Phase 3 trial compares ultrasound-guided perimeniscal injections of betamethasone versus isotonic saline in adults with MRI-confirmed degenerative meniscal lesions and persistent knee pain. Participants receive a single ultrasound-guided infiltration into the posterior meniscal wall and are followed for pain outcomes, with the primary endpoint at one month. Key inclusion criteria include localized joint-line tenderness, VAS pain >4 despite first-line analgesics, and a knee MRI within six months showing a degenerative meniscal lesion; key exclusions include unstable or complex meniscal tears and inability to consent. The trial is designed to provide higher-quality, placebo-controlled evidence to clarify the short-term effectiveness of perimeniscal corticosteroid injections.

Why it matters

Who can join: the full rules

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

Where it's running

• UHToulouse
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Marie FARUCH, MD — University Hospital, Toulouse
• Study coordinator: Marie FARUCH, MD
• Email: faruch.m@chu-toulouse.fr
• Phone: 05 61 77 22 97

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.