Meniscal INfiltration of Corticosteroid Guided with Ultra Sonography

Launched by UNIVERSITY HOSPITAL, TOULOUSE · Jul 24, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating whether injecting a corticosteroid (a type of anti-inflammatory medication) directly into the meniscus (a cartilage in the knee) can help relieve pain from degenerative meniscal lesions. The injection will be guided by ultrasound, a technique that uses sound waves to create images of the inside of the body, ensuring the medication is delivered accurately. The researchers want to compare the effects of the corticosteroid injection to a placebo (a harmless substance with no active medicine) to see if the corticosteroid truly helps reduce pain more effectively.

To be eligible for this trial, participants should be between 65 and 74 years old and have knee pain that is localized and intense enough to score over 4 out of 10 on a pain scale, even after trying basic pain relief medications. They must have had an MRI in the last three months that shows a specific type of meniscal injury related to their pain. It’s important for potential participants to know that there are several criteria that might exclude them from the trial, such as having certain types of knee injuries, recent knee surgeries, or other health issues. If you qualify and decide to participate, you can expect to receive either the active treatment or the placebo and will be monitored for your pain levels over the course of the study.

Gender

ALL

Eligibility 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 3 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