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Recruiting Not applicable

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

NCT07539194 · tracked via the Priya Life Science Italy tracker
Sponsor
Phase
Not applicable
Started
2026-04-30
Last updated
2026-04-20

Condition(s) studied

Meniscus Tears

Investigational drug(s) / intervention(s)

Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose

Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose: Promovia Hydro Balance 100 mg

Study 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

Sex
ALL
Min age
35 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy — Change from Baseline in the evaluation at 6 Months
    To evaluate, through the Knee injury and Osteoarthritis Outcome Score (KOOS) functional score, the performance of intra-articular treatment with Promovia Hydro Balance at 6 months follow-up (T6) in the recovery of joint function and improvement of associated pain in patients affected by non-traumatic degenerative meniscus lesions

Trial sites (1)

FacilityCityRegionStatus
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO Milan MI Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07539194 on ClinicalTrials.gov ↗ ← All trials in Italy