Evaluation of the Performance of Six-month Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. A Single-center, Randomized, Double-blind Study.

NIMAO/2021-1/PM-01

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.

2022-05-12

2025-08-01

2025-11-01

Recruiting

Early phase I

70

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, randomized, double-blind, controlled study comparing two management strategies.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'The patient will not know whether he has been randomized to the meniscal wall infiltration group or the intra-articular filtration group. The investigator following up the patients after infiltration will not know whether his:her patient has had an intra-articular infiltration or a meniscal wall infiltration.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 70, 'type': 'ESTIMATED'}}

2024-05-17