Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears

Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears

Study Overview

• Status: Recruiting
• Conditions: Meniscus Tears
• Intervention / Treatment: Device: Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giulia Avio; Phone Number: +393925481157; Email: giulia.avio@innate.it
• Study Contact Backup: Name: Chiara Fossati, medical doctor; Phone Number: i; Email: chiara.fossati@asst-pini-cto.it

Study Locations

• Italy
  • MI
    • Milan, MI, Italy
      • Recruiting
      • ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
      • Contact: Chiara Fossati, medical doctor; Phone Number: +39 339 490 4652; Email: chiara.fossati@asst-pini-cto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with non-traumatic degenerative meniscus lesions	Device: Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose; Promovia Hydro Balance 100 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from Baseline in the evaluation at 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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	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	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	Change from Baseline at time of 6 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
AE and SAE	Presence of adverse events and serious adverse events at 3 months from T0	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	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	consumption of analgesic/fans at 3 months from T0
consumption of analgesic/fans	consumption of analgesic/fans at 6 months from T0	consumption of analgesic/fans at 6 months from T0

Collaborators and Investigators

• Sponsor: Innate srl
• Collaborators: ASST Gaetano Pini-CTO

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hyaluronic acid; viscosupplementation; meniscus tears; promovia hydro balance
• Other Study ID Numbers: PROHYBA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No