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New treatment option for Meniscus Lesion
Official title Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography
ClinicalTrials.gov ID: NCT06527235
What this study is testing
What is ultrasound-guided betamethasone infiltration of the meniscal wall?
ultrasound-guided betamethasone infiltration of the meniscal wall is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for meniscus lesion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- Patient with an MRI showing recent ligament injury(ies) (cruciate ligaments and/or collateral ligaments)
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toulouse, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toulouse, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.