Single-dose Promovia Hydro Balance injection for non‑traumatic degenerative meniscus tears
Official title: Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears
Run by Innate srl · NCT07539194 · Data updated 2026-11-12
This study will test whether a single injection of Promovia Hydro Balance (hyaluronic acid) reduces pain and improves knee function in adults 35–75 with non‑traumatic degenerative meniscus tears.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 35 Years to 75 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Innate srl Industry-sponsored |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | April 30, 2026 |
| Main results expected | November 30, 2026 |
| Study ends | January 30, 2027 |
| Registry record updated | April 20, 2026 |
| Trial ID | NCT07539194 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 35–75 with MRI‑confirmed symptomatic non‑traumatic degenerative meniscal tears, pain NRS ≥4, positive meniscal tests, and willingness to engage in physical therapy.
✕Probably not a fit
Patients with traumatic tears, meniscal lesions requiring surgery (e.g., flap, radial, RAMP tears), severe knee osteoarthritis, axial deformity >10°, recent meniscal or ligament surgery, rheumatic disease, or chondrocalcinosis are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study gives a single intra‑articular injection of Promovia Hydro Balance (100 mg/4 mL hyaluronic acid with trehalose) to adults with non‑traumatic degenerative meniscus tears. Participants are assessed with the Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline and primarily at 6 months to measure function and pain, with secondary measures of overall pain, stiffness, quality of life at 3 and 6 months, and recording of analgesic/NSAID use. Safety is monitored through adverse event reporting across follow‑up visits. Enrollment is limited by age and imaging confirmation and excludes traumatic tears or tears requiring surgical repair, and the study is conducted at a single center in Milan, Italy.
Why it matters
Potential benefit: If successful, a single injection could reduce knee pain and improve function, offering a non‑surgical option for many patients.
How similar studies have gone: Hyaluronic acid viscosupplementation has mixed evidence in knee osteoarthritis and only limited, preliminary positive data for degenerative meniscal tears, so this approach is somewhat supported but not definitively proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, Mi, Italy Recruiting
Study contacts
- Study coordinator: Giulia Avio
- Email: giulia.avio@innate.it
- Phone: +393925481157
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.