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 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT06906094
Eligibility Criteria:
Inclusion Criteria:
1. Signed Informed Consent Form;
2. Male or female patients ≥18 years of age at time of screening;
3. Patients physically and mentally able to comply with all aspects of the study, including the requirements for follow-up visits;
4. Patients suffering from symptomatic medial and/or lateral degenerative meniscal lesion identified at MRI with a surgical indication of arthroscopic partial meniscectomy;
5. In case of bilateral degenerative meniscus, patients with no or mild pain in the contralateral knee, defined as a score \< 2 on a 0-10 numerical rating scale (NRS);
6. Patients who, before the last 3 months, have undergone and failed at least one prior conservative OA treatment (NSAIDs, physiotherapy, hydrokinesitherapy);
7. Body mass index (BMI) ≤ 40 kg/m2
Exclusion Criteria:
1. Presence of clinically observed active infection in the index knee joint or skin disease/breakdown or infection in the area of the planned injection site of the index knee
2. Patients who experienced traumatic injury at the index knee within 6 months prior to the procedure;
3. Patients with a history of invasive malignancies (except non- melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for 5 years;
4. Patients with known systemic disorders or any systemic inflammatory condition such as rheumatoid arthritis;
5. Patients with known metabolic bone diseases such as those affecting calcium metabolism;
6. Patients with a BMI greater than 40 kg/m2,
7. Patients who abuse of the following substances: alcohol, recreational drugs;
8. Major surgery (e.g. osteotomy) of the index knee within 12 months prior to screening;
9. Minor surgery (e.g. shaving or arthroscopy) of the index knee within 6 months prior to screening;
10. Use of systemic immunosuppressants within 6 weeks prior to screening;
11. Any documented clinically significant degree of cognitive impairment or other condition, finding, or psychiatric illness at screening which, in the opinion of the investigator, could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06906094
Study Brief:
Protocol Section:
NCT06906094