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.