Meniscus Tears
Conditions
Keywords
meniscus tears, promovia hydro balance, hyaluronic acid, viscosupplementation
Brief summary
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
DEVICEPromovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
Promovia Hydro Balance 100 mg
Sponsors
Innate srl
ASST Gaetano Pini-CTO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy | Change from Baseline in the evaluation at 6 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance evaluation T3 with Koos Questionnaire | Change from Baseline in the evaluation at 3 Months | 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) | Change from Baseline in the evaluation at 3 Months | 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 | Change from Baseline in NRS at 3 month from T0 | 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 | Change from Baseline in NRS at 6 months from T0 | 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 |
| Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 6 months | Change from Baseline at time of 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 |
Countries
Italy
Contacts
CONTACTGiulia Avio
CONTACTChiara Fossati, medical doctor
Outcome results
None listed