An interventional study of Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose in Meniscus Tears, sponsored by Innate srl. Recruiting at 1 site in Italy. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-04-20.
Sponsored by Innate srl · Not applicable, Interventional, and Treatment
Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears
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.
Exclusion Criteria:
Device: Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
Promovia 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
Time frame: Change from Baseline in the evaluation at 6 Months
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
Time frame: Change from Baseline in the evaluation at 3 Months
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)
Time frame: Change from Baseline in the evaluation at 3 Months
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
Time frame: Change from Baseline in NRS at 3 month from T0
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
Time frame: Change from Baseline in NRS at 6 months from T0
Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 6 months
Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 6 months compared to baseline (T0). 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
Time frame: Change from Baseline at time of 6 months.
AE and SAE
Presence of adverse events and serious adverse events at 3 months from T0
Time frame: 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
Time frame: 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
Time frame: consumption of analgesic/fans at 3 months from T0
consumption of analgesic/fans
consumption of analgesic/fans at 6 months from T0
Time frame: consumption of analgesic/fans at 6 months from T0
Plan to share: No
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