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.
Innate srl is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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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Start is estimated for Apr 2026; primary completion for Nov 2026, 7 months later.
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