Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose.
- Who it may be relevant to
- Registry conditions: Meniscus Tears. Basic parameters: 35 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears
Detailed 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.
Interventions
- Device Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
Promovia Hydro Balance 100 mg
Primary outcome measures
- Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy [Time frame: Change from Baseline in the evaluation at 6 Months]
Secondary outcome measures (5)
- Performance evaluation T3 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) [Time frame: Change from Baseline in the evaluation at 3 Months]
- Numerical Rating Scale (NRS) at T3 compared to baseline [Time frame: Change from Baseline in NRS at 3 month from T0]
- Numerical Rating Scale (NRS) at 6 months [Time frame: Change from Baseline in NRS at 6 months from T0]
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 6 months [Time frame: Change from Baseline at time of 6 months.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO — Milan
Identifiers
NCT: NCT07539194 · PROHYBA