Clinical Trials in Italy / NCT07539194
Recruiting
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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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO | Milan | MI | Recruiting |
More Innate srl trials in Italy
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