RecruitingPhase 1NCT05235854

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

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


Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

70 participants

Start Date

May 12, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria11

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGInjection 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(1)

Chu Nimes

Nîmes, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05235854


Related Trials