Meniscus LesionPhase 3MINUSNCT06527235
Meniscal INfiltration of Corticosteroid Guided With Ultra Sonography
A Phase 3 study testing ultrasound-guided betamethasone infiltration of the meniscal wall in people with Meniscus Lesion, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniscus Lesion
- What is being tested?
- ultrasound-guided betamethasone infiltration of the meniscal wall
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- 6 Mar 2025to 1 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- History of knee trauma less than 3 months
- History of arthroscopy or open surgery of the involved knee,
- History of corticosteroid injection in the knee concerned in the 3 months preceding inclusion,
- Use of NSAIDs and oral corticosteroids during the 48 hours preceding inclusion
- Use of tier 3 analgesics for gonalgia in the 3 months prior to inclusion
- 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
- Contraindication to the use of lidocaine: known hypersensitivity to lidocaine hydrochloride, to local anaesthetics with an amide bond or to one of the excipients, patients with recurrent porphyrias
- Patients on anticoagulants
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Virginie SICART contact
France1 site, 1 recruiting
- Recruiting
UHToulouse
Toulouse
Virginie SICART, sicart.v@chu-toulouse.fr
Marie FARUCH, PU PH
About this study
Official title: Efficacy of Ultrasound-monitored Meniscal Wall Betamethasone Infiltration on Pain in Relation to Degenerative Meniscal Injury: a Randomized, Double-blind, Placebo-controlled Multicenter 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.
Read the detailed description
"Meniscal pain" is a very frequent cause of consultation in orthopedics, rheumatology or sports medicine. The management of degenerative meniscal lesions has been the subject of a consensus conference by the French Authority (2008) and a recommendation by the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA 2017), which propose symptomatic medical treatment before any surgical management. Conservative medical treatment is the first-line treatment for most patients with symptomatic meniscal injuries with a wide range of therapies including rehabilitation, oral nonsteroidal anti-inflammatory drugs, joint injections of corticosteroid, hyaluronic acid, or platelet concentrates, as well as injection of corticosteroids into the posterior meniscal wall. In the therapeutic arsenal, corticosteroid infiltrations of the posterior meniscus wall are those that have been the subject of the most clinical studies, yet the data in the literature on the efficacy of these corticosteroid infiltrations are of low level of evidence. This is why the European Society of Musculoskeletal Radiology's Delphi-based consensus group on musculoskeletal imaging (ESSR) is encouraging the development of clinical research in this field with a placebo control group, in order to allow an objective validation of perimeniscal corticosteroid injection procedures in the treatment of meniscal pain of degenerative origin.
The present study is a multicenter randomized controlled trial in double blind (patient and evaluator) versus placebo. Only the physician performing the infiltration will know the status of the group assigned to the patient (experimental or placebo).
Enrollment will be prospective from the active line of patients followed in the investigating centers. A telephone pre-inclusion visit will be done at least 7 days before the inclusion visit. The inclusion visit, randomization (stratified on the centre) and infiltration will be performed on the same day. The follow-up will include a consultation at 1 month and two phone call at 7 days and 3 months.
- Conditions
- Meniscus Lesion
- Being tested
- ultrasound-guided betamethasone infiltration of the meniscal wall, ultrasound-guided isotonic saline (placebo) infiltration of the meniscal wall
- Keywords
- Betamethasone Injections, Meniscus, Ultrasonography, Randomized controlled Trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided betamethasone infiltration of the meniscal wallDrug
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 wallDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: ultrasound-guided isotonic saline (placebo) infiltration of the meniscal wall |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: month 1
Secondary outcomes (5)
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
Measured: month 3
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
Measured: month 1
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
Measured: month 3
adverse events
the occurrence of adverse events (AEs) and serious AEs (SAEs) up to 3 months of follow-up
Measured: month 3
Analgesic response at the 1-month follow-up visit
Analgesic response is defined as a at least 50% reduction in pain (measured using the VAS scale) between the initial visit and the 1-month follow-up visit
Measured: month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start6 Mar 2025
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus LesionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie FARUCH, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527235
- Sponsor's protocol ID
- RC31/23/0387
- Other IDs
- 2023-510079-74-00, 2023
- Acronym
- MINUS
- Status last verified
- Nov 2025
- First submitted
- 24 Jul 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ultrasound-monitored Meniscal Wall Betamethasone Infiltration on Pain in Relation to Degenerative Meniscal Injury: a Randomized, Double-blind, Placebo-controlled Multicenter Trial.
- ClinicalTrials.gov ID
- NCT06527235
- Acronym / sponsor ID
- MINUS / RC31/23/0387
- Conditions
- Meniscus Lesion
- Keywords
- Betamethasone Injections, Meniscus, Ultrasonography, Randomized controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 6 Mar 2025 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 30 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"Meniscal pain" is a very frequent cause of consultation in orthopedics, rheumatology or sports medicine. The management of degenerative meniscal lesions has been the subject of a consensus conference by the French Authority (2008) and a recommendation by the European Society of Sports Traumatology, Knee Surgery and Arthroscopy (ESSKA 2017), which propose symptomatic medical treatment before any surgical management. Conservative medical treatment is the first-line treatment for most patients with symptomatic meniscal injuries with a wide range of therapies including rehabilitation, oral nonsteroidal anti-inflammatory drugs, joint injections of corticosteroid, hyaluronic acid, or platelet concentrates, as well as injection of corticosteroids into the posterior meniscal wall. In the therapeutic arsenal, corticosteroid infiltrations of the posterior meniscus wall are those that have been the subject of the most clinical studies, yet the data in the literature on the efficacy of these corticosteroid infiltrations are of low level of evidence. This is why the European Society of Musculoskeletal Radiology's Delphi-based consensus group on musculoskeletal imaging (ESSR) is encouraging the development of clinical research in this field with a placebo control group, in order to allow an objective validation of perimeniscal corticosteroid injection procedures in the treatment of meniscal pain of degenerative origin.
The present study is a multicenter randomized controlled trial in double blind (patient and evaluator) versus placebo. Only the physician performing the infiltration will know the status of the group assigned to the patient (experimental or placebo).
Enrollment will be prospective from the active line of patients followed in the investigating centers. A telephone pre-inclusion visit will be done at least 7 days before the inclusion visit. The inclusion visit, randomization (stratified on the centre) and infiltration will be performed on the same day. The follow-up will include a consultation at 1 month and two phone call at 7 days and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ultrasound-guided betamethasone infiltration of the meniscal wall | Experimental | Drug: ultrasound-guided betamethasone infiltration of the meniscal wallpatients allocated to the experimental group will receive a single betamethasone infiltration (1mL) of the meniscal wall under ultrasound guidance. |
| ultrasound-guided physiological serum infiltration of the meniscal wall | Placebo comparator | Drug: ultrasound-guided isotonic saline (placebo) infiltration of the meniscal wallpatients allocated to the control group will receive a single placebo infiltration of isotonic saline (1mL) of the meniscal wall under ultrasound guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound-guided betamethasone infiltration of the meniscal wallThe 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. | Drug | ultrasound-guided betamethasone infiltration of the meniscal wall |
| ultrasound-guided isotonic saline (placebo) infiltration of the meniscal wallThe 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. | Drug | ultrasound-guided physiological serum infiltration of the meniscal wall |
Primary outcome
meniscal pain at 1-month follow-up visit
Time frame: month 1
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
5 secondary outcomes
meniscal pain at 3-month follow-up visit
Time frame: month 3
algo-functional scale measured by KOOS score (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) at the 1-month follow-up visit
Time frame: month 1
algo-functional scale measured by KOOS score (KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE) at the 3-month follow-up visit
Time frame: month 3
adverse events
Time frame: month 3
Analgesic response at the 1-month follow-up visit
Time frame: month 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Virginie SICART contact
Marie FARUCH, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ultrasound-guided betamethasone infiltration of the meniscal wall in people with Meniscus Lesion, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie FARUCH, MD (05 61 77 22 97 ext. +33, faruch.m@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
meniscal pain at 1-month follow-up visit (time frame: month 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.