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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-75
SponsorInnate srl

About this trial

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 criteria

Qualifiers

- 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.

Disqualifiers

- 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°.

Trial design

Treatments tested in this trial

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

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators

Innate srl

Lead sponsor

ASST Gaetano Pini-CTO

Collaborator