Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears
- 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.
- 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°.
Single group
Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
DevicePromovia Hydro Balance 100 mg
Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy
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
Performance evaluation T3 with Koos Questionnaire
Evaluate the performance of Promovia Hydro Balance in terms of improvement of general pain, joint stiffness and patient quality of life 3 (T3) after infiltration treatment. T3 evaluation with Koos questionnaire
Evaluation of performance T3 with Womac (Western Ontario and McMaster Universities Arthritis Index)
Secondary endpoints will consist of evaluating the performance of Promovia Hydro Balance in terms of improvement in overall pain, joint stiffness and patient quality of life at 3 months. Evaluation with Womac scale (Western Ontario and McMaster Universities Arthritis Index)
Numerical Rating Scale (NRS) at T3 compared to baseline
Numerical Rating Scale (NRS) at T3 compared to baseline (T0). econdary endpoints will consist of evaluating the performance of Promovia Hydro Balance in terms of improvement in overall pain, joint stiffness and patient quality of life
Numerical Rating Scale (NRS) at 6 months
Numerical Rating Scale (NRS) at 6 months compared to baseline. Secondary endpoints will consist of evaluating the performance of Promovia Hydro Balance in terms of improvement in overall pain, joint stiffness and patient quality of life
AE and SAE
Presence of adverse events and serious adverse events at 3 months from T0
AE and SAE
Presence of adverse events and serious adverse events at 6 months from T0
consumption of analgesic/fans
consumption of analgesic/fans at 3 months from T0
consumption of analgesic/fans
consumption of analgesic/fans at 6 months from T0
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Innate srl
Lead sponsor
ASST Gaetano Pini-CTO
Collaborator
