Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. (ECHOGUIDE)

Centre Hospitalier Universitaire de Nīmes

Status and phase: Enrolling; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Drug: Injection of corticosteroids (Diprostène®)

Study type: Interventional

Funder types: Other

Identifiers

NCT05235854

NIMAO/2021-1/PM-01

Details and patient eligibility

About

The main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of the intra-articular infiltration group.

The aim is to evaluate the effectiveness of meniscal wall infiltration under ultrasound in the treatment of stable degenerative meniscal lesions versus intra-articular infiltration (Gold standard) at 3 months by Lysholm's algo-functional score.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with a symptomatic meniscal lesion of a degenerative nature, isolated or associated with early osteoarthritis or chondropathy (Ahlbach stages 1 and 2).
• Indication for peri-meniscal infiltration under ultrasound control of the knee for a clinically stable degenerative meniscal lesion confirmed by MRI and radiography.
• Patient who has given free and informed consent.
• Patient who has signed the consent form.
• Patient affiliated or beneficiary of a health insurance plan.
• Adult patient (≥18 years of age).

Exclusion criteria

• No iconographic evidence of meniscal injury.
• Associated lesions of the central pivot of the knee.
• Knee pain of osteoarthritic origin strongly suggested by the clinic associated with an advanced radiological stage of osteoarthritis (Ahlbach stages 3 and 4).
• Presence of a skin lesion at the infiltration sites.
• Suspected soft tissue or joint infection.
• Patient participating in research involving human subjects defined as Category 1.
• Patient in an exclusion period as determined by another study.
• Patient under court protection, guardianship or trusteeship.
• Patient unable to give consent.
• Patient for whom it is impossible to give informed information.
• Pregnant, parturient or breastfeeding women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Meniscal wall infiltration group

Active Comparator group

Description:

Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control.

Treatment:

Drug: Injection of corticosteroids (Diprostène®)

Intra-articular infiltration group

Active Comparator group

Description:

The procedure is identical in all respects to the experimental group, except that the ultrasound procedure is mimicked and the infiltration of dexamethasone 2 mg (Diprostene®) is performed intra-articularly. Administration Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe.

Treatment:

Drug: Injection of corticosteroids (Diprostène®)