Osteoarthritis, Knee
Conditions
Keywords
knee,, osteoarthritis,, meniscus,, Lysholm score,, corticoids, infiltration
Brief summary
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.
Interventions
DRUGInjection of corticosteroids (Diprostène®)
Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
Single-center, randomized, double-blind, controlled study comparing two management strategies.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm score before infiltration (intra-articular group) | 15 days before infiltration | 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) |
| Lysholm score before infiltration (meniscal wall group) | 15 days before infiltration | 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) |
| Lysholm score after infiltration (intra-articular group) | 3 months after infiltration | 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) |
| Lysholm score after infiltration (meniscal wall group) | 3 months after infiltration | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arthroscopy required within six months of infiltration: (intra-articular group) | 6 months after infiltration | Yes/No and, if so, the date of the arthroscopy will be recorded. |
| Arthroscopy required within six months of infiltration: (meniscal wall group) | 6 months after infiltration | Yes/No and, if so, the date of the arthroscopy will be recorded. |
| Pain evaluated by the patient (intra-articular group) | 15 days before infiltration | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. |
| Pain evaluated by the patient (meniscal wall group) | 15 days before infiltration | Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration. |
| Return to physical activity (intra-articular infiltration group) | Day 0 to Month 6 | The number of days taken for the patient to return to physical activity |
| Return to physical activity (meniscal wall infiltration group) | Day 0 to Month 6 | The number of days taken for the patient to return to physical activity |
| Adverse events in the intra-articular infiltration group | Day 0 to 3 months after infiltration | Collection of all possible adverse events from D0 to M3. Qualitative |
| Adverse events in the meniscal wall infiltration group | Day 0 to 3 months after infiltration | Collection of all possible adverse events from D0 to M3. Qualitative |
Countries
France
Outcome results
None listed