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Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography

ConditionMeniscus Lesion
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

The value of corticosteroid infiltration of the meniscus wall in the therapeutic strategy is not clearly defined: the data in the literature on the effectiveness of corticosteroid infiltration are heterogeneous and of low level of proof. We hypothesize that corticosteroid infiltration of the meniscal wall under ultrasound control would be effective for rapid relief of degenerative meniscal pain.

The main objective is to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo, at 1 month, on meniscal pain in the treatment of meniscal pain of degenerative origin in adult.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Localized knee pain with tenderness over the medial or lateral joint space reproduced on clinical examination

Pain assessed with a VAS score > 4/10 despite first-line medical treatment including the use of tier I or II analgesics or NSAIDs.

An MRI of the knee performed in the 6 months preceding the operation as part of the pre-treatment assessment

Medial or lateral degenerative meniscal lesion on MRI consistent with pain, confirmed by an investigating physician

Disqualifiers

Patient under curatorship, guardianship or safeguard of justice

Inability to speak, read or write French fluently

Patient deprived of liberty

Patients with psychiatric pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound-guided betamethasone infiltration of the meniscal wall

    Drug

    The perimeniscal injections will be guided by ultrasound with an 18 megahertz (MHz) linear probe under strict aseptic conditions. Doppler will be systematically used before the injection to identify the medial or lateral inferior geniculate artery. The first step will consist of local anesthesia with 2 ml of lidocaine injected into the subcutaneous tissues and close to the meniscus wall using a 25-gauge needle. Using an in-plane approach, a 21-gauge needle will be positioned under ultrasound guidance in the medial or lateral wall of the meniscus. Once the needle touches the meniscus wall, it will be withdrawn 1 mm, and a 1-ml injection of betamethasone into the meniscus wall will be performed.

  • ultrasound-guided isotonic saline (placebo) infiltration of the meniscal wall

    Drug

    The perimeniscal injections will be guided by ultrasound with an 18 MHz linear probe under strict aseptic conditions. Doppler will be systematically used before the injection to identify the medial or lateral inferior geniculate artery. The first step will consist of local anesthesia with 2 ml of isotonic saline injected into the subcutaneous tissues and close to the meniscus wall using a 25-gauge needle. Using an in-plane approach, a 21-gauge needle will be positioned under ultrasound guidance in the medial or lateral wall of the meniscus. Once the needle touches the meniscus wall, it will be withdrawn 1 mm, and a 1-ml injection of betamethasone into the meniscus wall will be performed.

Treatment groups

152 Participants
are divided into 2 treatment groups
Group A: ultrasound-guided betamethasone infiltration of the meniscal wallExperimental treatment 1 intervention
Group B: ultrasound-guided physiological serum infiltration of the meniscal wallPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

meniscal pain at 1-month follow-up visit

meniscal pain measured using the Visual Analog Scale (VAS) rated from 0 to 10 at 1-month follow-up visit compared to baseline VAS score

Time frame
month 1

Secondary outcomes

1

meniscal pain at 3-month follow-up visit

meniscal pain measured using the Visual Analog Scale (VAS) rated from 0 to 10 at 3-month follow-up visit compared to baseline VAS score

Time frame
month 3
2

algo-functional scale measured by KOOS score (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) at the 1-month follow-up visit

KOOS score (algo-functional scale) at 1-month follow-up visit compared to baseline KOOS score

Time frame
month 1
3

algo-functional scale measured by KOOS score (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) at the 3-month follow-up visit

KOOS score (algo-functional scale) at 3-month follow-up visit compared to baseline KOOS score

Time frame
month 3
4

adverse events

the occurrence of adverse events (AEs) and serious AEs (SAEs) up to 3 months of follow-up

Time frame
month 3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Toulouse

Lead sponsor

Source ClinicalTrials.gov
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