Evaluation of Ultrasound-Guided Betamethasone Infiltration for Degenerative Meniscal Pain: A Randomized, Double-Blind, Placebo-Controlled Trial
- Trial ID
- 2023-510079-74-00
- Protocol
- RC31/23/0387
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **efficacy** of ultrasound-guided meniscal wall infiltration of betamethasone compared to placebo in the treatment of meniscal pain of degenerative origin in adults, specifically assessing pain relief at one month. This is clinically relevant as it aims to determine the potential benefits of betamethasone in managing degenerative meniscal pain, which can significantly impact patient quality of life and functional ability.
Secondary objectives include:
- Evaluating the efficacy of the treatment on meniscal pain at three months.
- Assessing the impact on functional activity at one and three months.
- Evaluating the safety profile of the ultrasound-guided meniscal wall infiltration.
- Assessing the impact of the severity of the degenerative meniscal lesion on the analgesic response.
Participants
The clinical trial focuses on evaluating the efficacy of ultrasound-guided meniscal wall infiltration of betamethasone versus placebo in treating **meniscal pain of degenerative origin** in adults. The study population includes both male and female participants aged 18 years and older, with a specific focus on individuals experiencing localized knee pain with tenderness over the medial or lateral joint space, as confirmed by clinical examination. Participants must have a pain level assessed with a Visual Analog Scale (VAS) score greater than 4/10, despite first-line medical treatment, and a confirmed medial or lateral degenerative meniscal lesion on MRI. The trial includes individuals affiliated with Social Security and requires free and informed consent. The sponsor has not provided the total number of participants involved in the study. The trial population selection considers the presence of a vulnerable population, although specific lifestyle considerations such as diet or physical activity are not detailed in the available data.
Plans and Procedures
The clinical trial is designed to evaluate the efficacy of **ultrasound**-guided meniscal wall infiltration of **betamethasone** compared to a placebo in treating meniscal pain of degenerative origin. This study is a randomized, double-blind, placebo-controlled multicenter trial. The trial is expected to commence recruitment on September 1, 2024, and conclude by December 1, 2027. Participants will be randomly assigned to receive either the active treatment or placebo, with both groups receiving injections under ultrasound guidance.
The trial will involve several key visits: an initial screening visit, follow-up visits at 1 month and 3 months, and an end-of-study visit. During the screening visit, eligibility will be confirmed based on criteria such as age (≥18 years), presence of localized knee pain, and MRI-confirmed degenerative meniscal lesions. Participants will provide informed consent and undergo baseline assessments, including pain evaluation using the Visual Analog Scale (VAS).
Follow-up visits will assess the primary endpoint, which is the change in meniscal pain measured by the VAS between the initial visit and the 1-month follow-up. Secondary endpoints include the evolution of the VAS and KOOS scores at 1 and 3 months, as well as the occurrence of adverse events. The end-of-study visit will finalize data collection and ensure participant safety.
Participant involvement is expected to last approximately 3 months, with conditions for early termination including withdrawal of consent, significant adverse events, or protocol non-compliance. The trial aims to provide robust data on the analgesic efficacy of betamethasone in this patient population, contributing to improved management of degenerative meniscal pain.
Treatment
The clinical trial involves the administration of **DIPROSTENE**, a suspension for injection containing **betamethasone dipropionate** and **betamethasone sodium phosphate**. This pharmaceutical product is provided in a pre-filled syringe and is manufactured by ORGANON_FRANCE. The active substances are of chemical origin, and the product is authorized for use in France. The maximum daily dose is 1 ml, with a total treatment period of 1 day. The route of administration is via injection, and the product is utilized as the test treatment in the trial.
As a comparator treatment, **Sodium Chloride Injection BP 0.9% w/v** is used, which serves as a placebo. This product is an injection solution containing **sodium chloride** and is manufactured by HAMELN PHARMA LTD. The active substance is of chemical origin, and the product is authorized in the United Kingdom. The maximum daily dose is 1 ml, with a total treatment period of 1 day. The route of administration is also via injection.
Additionally, **CHLORHYDRATE DE LIDOCAINE RENAUDIN 10 mg/ml**, a solution for injection containing **lidocaine hydrochloride**, is used as an auxiliary treatment. This product is manufactured by LABORATOIRE RENAUDIN and is authorized in France. The active substance is of chemical origin. The maximum daily dose is 2 ml, with a total treatment period of 1 day. The route of administration is subcutaneous use. This auxiliary treatment is included to facilitate the administration of the test and placebo treatments.
Efficacy
Efficacy in this clinical trial will be assessed by evaluating the impact of ultrasound-guided meniscal wall infiltration of **betamethasone** compared to a placebo on meniscal pain of degenerative origin in adults. The primary endpoint is the change in meniscal pain, which will be measured using the Visual Analog Scale (VAS) between the initial visit and the 1-month follow-up visit. Secondary endpoints include the evolution of the VAS score between the initial visit and the 3-month follow-up visit, the evolution of the Knee injury and Osteoarthritis Outcome Score (KOOS) between the initial visit and both the 1-month and 3-month follow-up visits, and the occurrence of adverse events (AEs) and serious adverse events (SAEs) up to 3 months of follow-up. Additionally, analgesic response is defined as at least a 50% reduction in pain, measured using the VAS scale, between the initial visit and the 1-month follow-up visit.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Patient aged ≥ 18 years
- 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
Exclusion Criteria
- Patient under 18 years of age
- Patient under curatorship or guardianship
- 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 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
- 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
- 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 Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Recruiting | 01 Sept 2024 | 152 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Sodium Chloride Injection BP 0.9% w/v | Placebo | INJECTION | INJECTION | 1 | 1 | PRD301483 |
CHLORHYDRATE DE LIDOCAINE RENAUDIN 10 mg/ml, solution injectable | Other | SOLUTION INJECTABLE | SUBCUTANEOUS USE | 2 | 1 | PRD2908411 |
DIPROSTENE, suspension injectable en seringue pré-remplie | Test | SUSPENSION INJECTABLE EN SERINGUE PRE-REMPLIE | INJECTION | 1 | 1 | PRD8891787 |