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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Knee Injury Osteoarthritis Outcome Score (KOOS) will be measured