Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries.

Osteoarthritis, Knee Clinical Trial

— ECHOGUIDE  

Official title:

Evaluation of the Performance of Six-month Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. A Single-center, Randomized, Double-blind Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235854
• Other study ID #: NIMAO/2021-1/PM-01
• Status: Recruiting
• Phase: Phase 1
• Start date: May 12, 2022
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Philippe MARCHAND, Dr.
• Phone: +33 4.66.68.72.93
• Email: philippe.marchand[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of the intra-articular infiltration group.

The aim is to evaluate the effectiveness of meniscal wall infiltration under ultrasound in the treatment of stable degenerative meniscal lesions versus intra-articular infiltration (Gold standard) at 3 months by Lysholm's algo-functional score.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a symptomatic meniscal lesion of a degenerative nature, isolated or associated with early osteoarthritis or chondropathy (Ahlbach stages 1 and 2).

• Indication for peri-meniscal infiltration under ultrasound control of the knee for a clinically stable degenerative meniscal lesion confirmed by MRI and radiography.

• Patient who has given free and informed consent.

• Patient who has signed the consent form.

• Patient affiliated or beneficiary of a health insurance plan.

• Adult patient (=18 years of age).

Exclusion Criteria:

• No iconographic evidence of meniscal injury.

• Associated lesions of the central pivot of the knee.

• Knee pain of osteoarthritic origin strongly suggested by the clinic associated with an advanced radiological stage of osteoarthritis (Ahlbach stages 3 and 4).

• Presence of a skin lesion at the infiltration sites.

• Suspected soft tissue or joint infection.

• Patient participating in research involving human subjects defined as Category 1.

• Patient in an exclusion period as determined by another study.

• Patient under court protection, guardianship or trusteeship.

• Patient unable to give consent.

• Patient for whom it is impossible to give informed information.

• Pregnant, parturient or breastfeeding women.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Injection of corticosteroids (Diprostène®)
Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe.

Locations

Country	Name	City	State
France	Chu Nimes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lysholm score before infiltration (intra-articular group)	The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)	15 days before infiltration
Primary	Lysholm score before infiltration (meniscal wall group)	The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)	15 days before infiltration
Primary	Lysholm score after infiltration (intra-articular group)	The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)	3 months after infiltration
Primary	Lysholm score after infiltration (meniscal wall group)	The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)	3 months after infiltration
Secondary	Arthroscopy required within six months of infiltration: (intra-articular group)	Yes/No and, if so, the date of the arthroscopy will be recorded.	6 months after infiltration
Secondary	Arthroscopy required within six months of infiltration: (meniscal wall group)	Yes/No and, if so, the date of the arthroscopy will be recorded.	6 months after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	15 days before infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	1 week after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	2 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	3 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	4 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	5 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	6 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	7 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	8 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	9 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	10 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	11 weeks after infiltration
Secondary	Pain evaluated by the patient (intra-articular group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	12 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	15 days before infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	1 week after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	2 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	3 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	4 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	5 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	6 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	7 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	8 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	9 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	10 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	11 weeks after infiltration
Secondary	Pain evaluated by the patient (meniscal wall group)	Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.	12 weeks after infiltration
Secondary	Return to physical activity (intra-articular infiltration group)	The number of days taken for the patient to return to physical activity	Day 0 to Month 6
Secondary	Return to physical activity (meniscal wall infiltration group)	The number of days taken for the patient to return to physical activity	Day 0 to Month 6
Secondary	Adverse events in the intra-articular infiltration group	Collection of all possible adverse events from D0 to M3. Qualitative	Day 0 to 3 months after infiltration
Secondary	Adverse events in the meniscal wall infiltration group	Collection of all possible adverse events from D0 to M3. Qualitative	Day 0 to 3 months after infiltration