Clinical trial NCT05235854: Six-month Performance of Meniscal Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Osteoarthritis, Knee
Keywords: knee,
osteoarthritis,
meniscus,
Lysholm score,
corticoids
infiltration
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-center, randomized, double-blind, controlled study comparing two management strategies.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lysholm score before infiltration (intra-articular group)
timeFrame: 15 days before infiltration
measure: Lysholm score before infiltration (meniscal wall group)
timeFrame: 15 days before infiltration
measure: Lysholm score after infiltration (intra-articular group)
timeFrame: 3 months after infiltration
measure: Lysholm score after infiltration (meniscal wall group)
timeFrame: 3 months after infiltration
Secondary outcomes:
measure: Arthroscopy required within six months of infiltration: (intra-articular group)
timeFrame: 6 months after infiltration
measure: Arthroscopy required within six months of infiltration: (meniscal wall group)
timeFrame: 6 months after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 15 days before infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 1 week after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 2 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 3 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 4 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 5 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 6 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 7 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 8 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 9 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 10 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 11 weeks after infiltration
measure: Pain evaluated by the patient (intra-articular group)
timeFrame: 12 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 15 days before infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 1 week after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 2 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 3 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 4 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 5 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 6 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 7 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 8 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 9 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 10 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 11 weeks after infiltration
measure: Pain evaluated by the patient (meniscal wall group)
timeFrame: 12 weeks after infiltration
measure: Return to physical activity (intra-articular infiltration group)
timeFrame: Day 0 to Month 6
measure: Return to physical activity (meniscal wall infiltration group)
timeFrame: Day 0 to Month 6
measure: Adverse events in the intra-articular infiltration group
timeFrame: Day 0 to 3 months after infiltration
measure: Adverse events in the meniscal wall infiltration group
timeFrame: Day 0 to 3 months after infiltration
Other outcomes:
Locations:
city: Nimes
country: France
facility: Chu Nimes
Study officials:
References: