Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injectio… (NCT05322005) | Clinical Trial Compass
CompletedNot Applicable
Study of Clinical Performance and Safety of Treatments in Degenerative Meniscopathy With Injection of Polynucleotides
Belgium, Italy60 participantsStarted 2020-10-26
Plain-language summary
This is a non-randomized multicentre study for the evaluation of the clinical performance and safaty of the augmentation-to-surgery and conservative treatments for the degenerative meniscopathies, with injection of polynucleotide gel.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Male or female subjects with age between 18 and 65 years
✓. Presence of symptomatic degenerative meniscus tear
✓. Presence of one of the following unilateral symptoms: pain, catching, or locking of the knee
✓. Non responsive to physical therapy for at least 3-4 weeks
✓. Be in neutral alignment +/- 5 degrees of the mechanical axis
✓. Subject must be physically and mentally willing and able to comply with the study follow-up schedule
✓. Subject must sign Ethic committe approved informed consent
✓. Subject is willing and able to comply with all study procedures, including visits and diagnostic procedures
Exclusion criteria
✕. Radiographic osteoarthritis of the knee in any compartment greater than Kellgren-Lawrence (KL) grade 3.
✕. Presence of bone marrow edema (BME) at the index knee.
✕. Presence of knee instability.
✕. Have a varus or valgus knee deformity \> 5 degrees.
✕. Have meniscal roots tears.
✕
What they're measuring
1
Overall Knee Injury Osteoarthritis Outcome Score (KOOS) will be measured