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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Promovia Hydro Balance 100 mg
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, MI, Italy
RECRUITINGEvalution 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
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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.