RecruitingNot ApplicableNCT07539194
Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears
Sponsor
Innate srl
Enrollment
25 participants
Start Date
Apr 30, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears
Eligibility
Min Age: 35 YearsMax Age: 75 Years
Inclusion Criteria7
- \- Age between 35 and 75 years at the time of administration.
- Presence of a symptomatic degenerative meniscus tear, not related to acute trauma, documented by MRI.
- Positive meniscal tests.
- Pain intensity NRS ≥ 4.
- Willingness to participate in physical therapy or light exercise.
- Informed consent received, understood, and signed by the patient for active participation in the study and for the processing of personal data.
- Ability of the patient to understand the study conditions and to participate for the entire duration of the study.
Exclusion Criteria11
- \- Patients with traumatic meniscus tears.
- Patients with a meniscal tear requiring surgical treatment (FLAP tear, radial tear, RAMP tear).
- Patients with severe knee osteoarthritis.
- Patients with axial deviation greater than 10°.
- Patients who have undergone meniscal or ligament surgery in the previous 12 months.
- Patients with rheumatic diseases or chondrocalcinosis.
- Patients with signs of possible infection in the affected joint or a skin disease involving the knee (e.g., dermatitis, psoriasis).
- Patients with diabetes.
- Patients with coagulopathies, platelet aggregation disorders, or those receiving oral anticoagulants or antiplatelet drugs.
- Patients receiving intra-articular corticosteroids or hyaluronic acid in the previous 12 months.
- Pregnant or breastfeeding patients.
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Interventions
DEVICEPromovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
Promovia Hydro Balance 100 mg
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07539194