Ultrasound-guided betamethasone injection into the meniscal wall
Efficacy of Ultrasound-monitored Meniscal Wall Betamethasone Infiltration on Pain in Relation to Degenerative Meniscal Injury: a Randomized, Double-blind, Placebo-controlled Multicenter Trial.
This trial will test whether an ultrasound-guided betamethasone injection into the meniscal wall provides faster pain relief than a saline injection for adults with degenerative meniscal pain.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 152 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT06527235 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with MRI-confirmed degenerative medial or lateral meniscal lesions who have localized joint-line pain with VAS >4 despite first-line analgesics and who can consent and attend the Toulouse site.
Not a fit: Patients with unstable, large, or complex meniscal tears, those without MRI confirmation, or those unable to consent, speak French, or attend follow-up are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If effective, this could provide rapid, minimally invasive short-term pain relief and help avoid or delay surgery for people with degenerative meniscal pain.
How similar studies have performed: Existing studies of perimeniscal corticosteroid injections are small and show inconsistent results, so a placebo-controlled phase 3 trial is needed to produce more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toulouse
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.