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

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: Injection of corticosteroids (Diprostène®)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-center, randomized, double-blind, controlled study comparing two management strategies.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Meniscal wall infiltration group<br>Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control. | Drug: Injection of corticosteroids (Diprostène®)<br>* Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe.<br>|
| Active Comparator: Intra-articular infiltration group<br>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. | Drug: Injection of corticosteroids (Diprostène®)<br>* Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 15 days before infiltration | 
| Lysholm score before infiltration (meniscal wall 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) | 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) | 3 months after infiltration | 
| Lysholm score after infiltration (meniscal wall 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) | 3 months after infiltration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arthroscopy required within six months of infiltration: (intra-articular group) | Yes/No and, if so, the date of the arthroscopy will be recorded. | 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. | 6 months after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 15 days before infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 1 week after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 2 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 3 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 4 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 5 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 6 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 7 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 8 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 9 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 10 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 11 weeks after infiltration | 
| Pain evaluated by the patient (intra-articular group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 12 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 15 days before infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 1 week after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 2 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 3 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 4 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 5 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 6 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 7 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 8 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 9 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 10 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 11 weeks after infiltration | 
| Pain evaluated by the patient (meniscal wall group) | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. | 12 weeks after infiltration | 
| Return to physical activity (intra-articular infiltration group) | The number of days taken for the patient to return to physical activity | Day 0 to Month 6 | 
| Return to physical activity (meniscal wall infiltration group) | The number of days taken for the patient to return to physical activity | Day 0 to Month 6 | 
| Adverse events in the intra-articular infiltration group | Collection of all possible adverse events from D0 to M3. Qualitative | Day 0 to 3 months after infiltration | 
| Adverse events in the meniscal wall infiltration group | Collection of all possible adverse events from D0 to M3. Qualitative | Day 0 to 3 months after infiltration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee,, osteoarthritis,, meniscus,, Lysholm score,, corticoids, infiltration