Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography

NCT06527235 | Recruiting Phase 3

• 2 other identifiers: RC31/23/03872023-510079-74-00
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Meniscus Lesion

Keywords

Betamethasone Injections; Meniscus; Ultrasonography; Randomized controlled Trial

Outcome Measures

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

  month 1

Secondary Outcomes (5)

• meniscal pain at 3-month follow-up visit

  month 3

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

  month 1

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

  month 3

• adverse events

  month 3

• Analgesic response at the 1-month follow-up visit

  month 1

Study Arms (2)

ultrasound-guided betamethasone infiltration of the meniscal wall

EXPERIMENTAL

patients allocated to the experimental group will receive a single betamethasone infiltration (1mL) of the meniscal wall under ultrasound guidance.

Drug: ultrasound-guided betamethasone infiltration of the meniscal wall

ultrasound-guided physiological serum infiltration of the meniscal wall

PLACEBO COMPARATOR

patients allocated to the control group will receive a single placebo infiltration of isotonic saline (1mL) of the meniscal wall under ultrasound guidance.

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

Interventions

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.

ultrasound-guided physiological serum infiltration of the meniscal wall

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 betamethasone infiltration of the meniscal wall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Affiliation to the Social Security
• Free and informed consent signed by the patient

You may not qualify if:

• Patient under curatorship, guardianship or safeguard of justice
• Inability to speak, read or write French fluently
• Patient deprived of liberty
• Patients with psychiatric pathology
• Patient who has had an MRI showing an unstable meniscal lesion: complete vertical tear of more than 10 mm in length, capsulomeniscal disinsertion of more than 10 mm in length, complex tear, T2 hypersignal tear of liquid type with passage of liquid testifying to the spreading of the edges, tear with displaced meniscal fragment, lesion of a posterior meniscal brake, lesion of the meniscotibial or meniscofemoral attachment
• Patient with an MRI showing recent ligament injury(ies) (cruciate ligaments and/or collateral ligaments)
• History of knee trauma less than 3 months
• History of arthroscopy or open surgery of the involved knee,
• Episodes of knee instability or true locking
• Radiographic gonarthrosis with a Kellgren Lawrence stage \>1 authenticated on radiographic images taken within the last 6 months.
• Known inflammatory rheumatism
• Fibromyalgia as determined by the clinical investigator
• Pregnancy and breastfeeding in progress
• Contraindication to the use of injectable corticosteroids: septic arthritis, skin lesions at the injection site, severe coagulation disorders, hypersensitivity to one of the excipients
• Contraindication to the use of systemic corticosteroids: acute infection, untreated and uncontrolled chronic infection, psychiatric or ophthalmological pathologies, unbalanced diabetes, uncontrolled hypertension

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

UHToulouse

Toulouse, France

RECRUITING

Study Officials

• Marie FARUCH, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie FARUCH, MD

CONTACT

05 61 77 22 97; faruch.m@chu-toulouse.fr

Virginie SICART

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial will be double-blind (patient and evaluator). Only the physician performing the infiltration will know the status of the group assigned to the patient (experimental or placebo).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized vs placebo, controlled, comparative, superiority, with 2 parallel groups compared (ultrasound-guided betamethasone infiltration vs. physiological serum (identical volume) of the meniscal wall).

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 30, 2024
• Study Start: March 6, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)