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

NCT05235854 | Recruiting Phase 1

• 1 other identifier: NIMAO/2021-1/PM-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

knee,; osteoarthritis,; meniscus,; Lysholm score,; corticoids; infiltration

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (32)

• Arthroscopy required within six months of infiltration: (intra-articular group)

  6 months after infiltration

• Arthroscopy required within six months of infiltration: (meniscal wall group)

  6 months after infiltration

• Pain evaluated by the patient (intra-articular group)

  15 days before infiltration

• Pain evaluated by the patient (intra-articular group)

  1 week after infiltration

• Pain evaluated by the patient (intra-articular group)

  2 weeks after infiltration

Study Arms (2)

Meniscal wall infiltration group

ACTIVE COMPARATOR

Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control.

Drug: Injection of corticosteroids (Diprostène®)

Intra-articular infiltration group

ACTIVE COMPARATOR

The procedure is identical in all respects to the experimental group, except that the ultrasound procedure is mimicked and the infiltration of dexamethasone 2 mg (Diprostene®) is performed intra-articularly. Administration Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe.

Drug: Injection of corticosteroids (Diprostène®)

Interventions

Injection of corticosteroids (Diprostène®) DRUG

Diprostène® will be injected into the knee. This is a 1 ml syringe of Betamethasone 2 mg, suspension for injection in pre-filled syringe.

Intra-articular infiltration group; Meniscal wall infiltration group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Chu Nimes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Philippe MARCHAND, Dr.

CONTACT

+33 4.66.68.72.93; philippe.marchand@chu-nimes.fr

Anissa MEGZARI

CONTACT

+33 4.66.68.42.36; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The patient will not know whether he has been randomized to the meniscal wall infiltration group or the intra-articular filtration group. The investigator following up the patients after infiltration will not know whether his:her patient has had an intra-articular infiltration or a meniscal wall infiltration.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, double-blind, controlled study comparing two management strategies.

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: February 11, 2022
• Study Start: May 12, 2022
• Primary Completion: August 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 17, 2024

Record last verified: 2024-05

Locations

FR (1)