Betamethasone meniscal infiltration under ultrasound control: a randomized, double-blind, placebo-controlled multicenter trial.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Toulouse

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03], Diseases [C] - Musculoskeletal Diseases [C05]

Trial duration

6 Mar 2025 → ongoing

Decision date (initial)

2024-07-19

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 5

1. to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo in the treatment of meniscal pain of degenerative origin in adult on meniscal pain at 3 month
2. to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo in the treatment of meniscal pain of degenerative origin in adult on functional activity at 1 month
3. to evaluate the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus ultrasound-guided meniscal wall infiltration of placebo in the treatment of meniscal pain of degenerative origin in adult on functional activity at 3 month
4. to evaluate the safety profile of ultrasound-guided meniscal wall infiltration
5. Assess the impact of the severity of the degenerative meniscal lesion on the analgesic response of ultrasound-guided meniscal wall infiltration.

Conditions and MedDRA coding

meniscal pain of degenerative origin

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patient aged ≥ 18 years
2. Localized knee pain with tenderness over the medial or lateral joint space reproduced on clinical examination
3. Pain assessed with a VAS score > 4/10 despite first-line medical treatment including the use of tier I or II analgesics or NSAIDs
4. An MRI of the knee performed in the 6 months preceding the operation as part of the pre-treatment assessment
5. Medial or lateral degenerative meniscal lesion on MRI consistent with pain, confirmed by an investigating physician
6. Affiliation to the Social Security
7. Free and informed consent signed by the patient

Exclusion criteria 21

1. Patient under 18 years of age
2. Patient under curatorship or guardianship
3. Inability to speak, read or write French fluently
4. Patient deprived of liberty
5. Patients with psychiatric pathology
6. Patient who has had an MRI showing an unstable meniscal lesion confirmed by the coordinating radiologist: 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
7. Patient with an MRI showing recent ligament injury(ies) (cruciate ligaments and/or collateral ligaments)
8. History of knee trauma less than 3 months
9. History of arthroscopy or open surgery of the involved knee
10. History of corticosteroid injection in the knee concerned in the 3 months preceding inclusion
11. Use of NSAIDs and oral corticosteroids during the 48 hours preceding inclusion
12. Use of tier 3 analgesics for gonalgia in the 3 months prior to inclusion
13. Episodes of knee instability or true locking
14. Radiographic gonarthrosis with a Kellgren Lawrence stage > 1 authenticated on radiographic images taken within the last 6 months.
15. Known inflammatory rheumatism
16. Fibromyalgia as determined by the clinical investigator
17. Pregnancy and breastfeeding in progress
18. Contraindication to the use of injectable corticosteroids: septic arthritis, skin lesions at the injection site, severe coagulation disorders, hypersensitivity to one of the excipients
19. Contraindication to the use of systemic corticosteroids: acute infection, untreated and uncontrolled chronic infection, psychiatric or ophthalmological pathologies, unbalanced diabetes, uncontrolled hypertension
20. 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
21. Patients on anticoagulants

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is the change in meniscal pain measured using the Visual Analog Scale (VAS) between the initial visit and the 1-month follow-up visit

Secondary endpoints 5

1. the evolution of the VAS score between the initial visit and the 3-month follow-up visit
2. the evolution of the score of each dimension (Pain, Symptoms, Activities of daily living, Sport and recreation function, and Knee-related qualities of life) of the algo-functional scale KOOS (appendix 1) between the initial visit and the 1-month follow-up visit
3. the evolution of each dimension of the algo-functional scale KOOS score between the initial visit and the 3-month follow-up visit
4. the occurrence of adverse events (AEs) and serious AEs (SAEs) up to 3 months of follow-up
5. 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.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Toulouse

Sponsor organisation

Centre Hospitalier Universitaire De Toulouse

Address

2 Rue Viguerie, Tsa 80035 Tsa 80035

City

Toulouse Cedex 9

Postcode

31059

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

BELLOC

Public contact point

Organisation

Centre Hospitalier Universitaire De Toulouse

Contact name

BELLOC

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications