Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries.
NCT ID: NCT05235854
Last Updated: 2024-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2022-05-12
2025-11-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Meniscal wall infiltration group
Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control.
Injection 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.
Intra-articular infiltration group
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.
Injection 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.
Interventions
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Injection 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Locations
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Chu Nimes
Nîmes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NIMAO/2021-1/PM-01
Identifier Type: -
Identifier Source: org_study_id
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