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

Phase 1RecruitingNCT05235854

Centre Hospitalier Universitaire de Nīmes70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Lysholm score before infiltration (intra-articular group)

The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)

Time frame: 15 days before infiltration

Lysholm score before infiltration (meniscal wall group)

Time frame: 15 days before infiltration

Lysholm score after infiltration (intra-articular group)

The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)

Time frame: 3 months after infiltration

Lysholm score after infiltration (meniscal wall group)

Time frame: 3 months after infiltration

Secondary Outcomes

Arthroscopy required within six months of infiltration: (intra-articular group)

Yes/No and, if so, the date of the arthroscopy will be recorded.

Time frame: 6 months after infiltration

Arthroscopy required within six months of infiltration: (meniscal wall group)

Yes/No and, if so, the date of the arthroscopy will be recorded.

Time frame: 6 months after infiltration

Pain evaluated by the patient (intra-articular group)