Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance… (NCT07539194) | Clinical Trial Compass
RecruitingNot 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
Italy25 participantsStarted 2026-04-30
Plain-language 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
Who can participate
Age range35 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy
Timeframe: Change from Baseline in the evaluation at 6 Months