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

Innate srl

Status

Enrolling

Conditions

Meniscus Tears

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT07539194

PROHYBA

Details and patient eligibility

About

Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears

Full description

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.

Enrollment

25 estimated patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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.