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Completed

NCT Number: NCT05235854

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chu Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Lysholm score before infiltration (intra-articular group)

    Time frame: 15 days before infiltration

    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)

  2. Lysholm score before infiltration (meniscal wall group)

    Time frame: 15 days before infiltration

    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)

  3. Lysholm score after infiltration (intra-articular group)

    Time frame: 3 months after infiltration

    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)

  4. Lysholm score after infiltration (meniscal wall group)

    Time frame: 3 months after infiltration

    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)

Secondary outcomes

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

    Time frame: 6 months after infiltration

    Yes/No and, if so, the date of the arthroscopy will be recorded.

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

    Time frame: 6 months after infiltration

    Yes/No and, if so, the date of the arthroscopy will be recorded.

  3. Pain evaluated by the patient (intra-articular group)

    Time frame: 15 days before infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  4. Pain evaluated by the patient (intra-articular group)

    Time frame: 1 week after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  5. Pain evaluated by the patient (intra-articular group)

    Time frame: 2 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  6. Pain evaluated by the patient (intra-articular group)

    Time frame: 3 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  7. Pain evaluated by the patient (intra-articular group)

    Time frame: 4 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  8. Pain evaluated by the patient (intra-articular group)

    Time frame: 5 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  9. Pain evaluated by the patient (intra-articular group)

    Time frame: 6 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  10. Pain evaluated by the patient (intra-articular group)

    Time frame: 7 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  11. Pain evaluated by the patient (intra-articular group)

    Time frame: 8 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  12. Pain evaluated by the patient (intra-articular group)

    Time frame: 9 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  13. Pain evaluated by the patient (intra-articular group)

    Time frame: 10 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  14. Pain evaluated by the patient (intra-articular group)

    Time frame: 11 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  15. Pain evaluated by the patient (intra-articular group)

    Time frame: 12 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  16. Pain evaluated by the patient (meniscal wall group)

    Time frame: 15 days before infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  17. Pain evaluated by the patient (meniscal wall group)

    Time frame: 1 week after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  18. Pain evaluated by the patient (meniscal wall group)

    Time frame: 2 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  19. Pain evaluated by the patient (meniscal wall group)

    Time frame: 3 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  20. Pain evaluated by the patient (meniscal wall group)

    Time frame: 4 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  21. Pain evaluated by the patient (meniscal wall group)

    Time frame: 5 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  22. Pain evaluated by the patient (meniscal wall group)

    Time frame: 6 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  23. Pain evaluated by the patient (meniscal wall group)

    Time frame: 7 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  24. Pain evaluated by the patient (meniscal wall group)

    Time frame: 8 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  25. Pain evaluated by the patient (meniscal wall group)

    Time frame: 9 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  26. Pain evaluated by the patient (meniscal wall group)

    Time frame: 10 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  27. Pain evaluated by the patient (meniscal wall group)

    Time frame: 11 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  28. Pain evaluated by the patient (meniscal wall group)

    Time frame: 12 weeks after infiltration

    Pain will be evaluated by the patient on a visual analog scale (0-10) once a week up to 3 months after infiltration.

  29. Return to physical activity (intra-articular infiltration group)

    Time frame: Day 0 to Month 6

    The number of days taken for the patient to return to physical activity

  30. Return to physical activity (meniscal wall infiltration group)

    Time frame: Day 0 to Month 6

    The number of days taken for the patient to return to physical activity

  31. Adverse events in the intra-articular infiltration group

    Time frame: Day 0 to 3 months after infiltration

    Collection of all possible adverse events from D0 to M3. Qualitative

  32. Adverse events in the meniscal wall infiltration group

    Time frame: Day 0 to 3 months after infiltration

    Collection of all possible adverse events from D0 to M3. Qualitative

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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.

Acronym: ECHOGUIDE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Feb 11, 2022
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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