Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears

Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears

The aim of this study is to evaluate the performance of a single-dose intra-articular hyaluronic acid treatment (Promovia Hydro Balance 100 mg/4 mL; Innate S.r.l, Novi Ligure (AL), Italy) in restoring joint function and reducing associated pain. The safety of the treatment will also be assessed. Primary objective: To evaluate, using the Knee Injury and Osteoarthritis Outcome Score (KOOS), the performance of intra-articular treatment with Promovia Hydro Balance at a 6-month follow-up (T6) in restoring joint function and improving associated pain in patients with non-traumatic degenerative meniscal tears. Secondary objectives: To evaluate the performance of Promovia Hydro Balance in terms of improvement in overall pain, joint stiffness, and patient quality of life at 3 (T3) and 6 months (T6) following the injection. The safety of the treatment and the consumption of analgesics/NSAIDs will also be evaluated in the various phases of the study at the various follow-up times.

Inclusion Criteria: * \- 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 Criteria: * \- 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.