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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meniscal wall infiltration group | Active Comparator | Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control. |
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| Intra-articular infiltration group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of corticosteroids (Diprostène®) | Drug | Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Nimes | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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Single-center, randomized, double-blind, controlled study comparing two management strategies.
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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.
| 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 |
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 |