Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT05322005
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects with age between 18 and 65 years
2. Presence of symptomatic degenerative meniscus tear
3. Presence of one of the following unilateral symptoms: pain, catching, or locking of the knee
4. Non responsive to physical therapy for at least 3-4 weeks
5. Be in neutral alignment +/- 5 degrees of the mechanical axis
6. Subject must be physically and mentally willing and able to comply with the study follow-up schedule
7. Subject must sign Ethic committe approved informed consent
8. Subject is willing and able to comply with all study procedures, including visits and diagnostic procedures
Exclusion Criteria:
1. Radiographic osteoarthritis of the knee in any compartment greater than Kellgren-Lawrence (KL) grade 3.
2. Presence of bone marrow edema (BME) at the index knee.
3. Presence of knee instability.
4. Have a varus or valgus knee deformity \> 5 degrees.
5. Have meniscal roots tears.
6. Have discoid meniscus.
7. Have patella instability or non-anatomically positioned patella.
8. Have a knee flexion contracture \> 10 degrees.
9. Be unable to flex the knee to 90 degrees.
10. Have a leg length discrepancy causing a noticeable limp.
11. Have an active infection or tumor.
12. Have any type of knee joint inflammatory disease including Sjogren's syndrome.
13. Have neuropathic knee osteoarthropathy, also known as Charcot joint.
14. Any disorder or impairment that would interfere with evaluation of outcomes measures, such as neurological, degenerative muscular, psychiatric or cognitive conditions.
15. Participation to another clinical trial or clinical investigation in the previous 3 months.
16. BMI \> 35.
17. Prior knee arthroscopy within 6 months of study enrolment.
18. Unable to have an MRI scan.
19. Known allergy, sensitivity or intolerance to any of the components of the investigational device or to products originating from fish.
20. Positive history of human immunodeficiency virus antibodies, hepatitis B surface antigen or hepatitis C virus antibodies.
21. Autoimmune diseases, rheumatoid disease eg. Lupus erythematosus.
22. The subject is currently being treated with radiation and or chemotherapy.
23. Previous or ongoing alcohol abuse or dependence, use of illicit drugs within 1 year prior to enrolment.
24. Patients who are pregnant or planning to become pregnant during the planned period of participation in the study or who are breastfeeding. Women of child-bearing age must consent to use and actually make use of a highly effective contraceptive method, considered acceptable by the investigator, for the whole study duration.
25. Does not agree to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05322005
Study Brief:
Protocol Section:
NCT05322005