Meniscus TearsNCT07539194
Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears
A study testing Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose in people with Meniscus Tears, run by Innate srl at 1 site in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Meniscus Tears
- What is being tested?
- Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 30 Apr 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO
Milan, MI
Chiara Fossati, medical doctor, +39 339 490 4652, chiara.fossati@asst-pini-cto.it
About this study
Evaluation of the performance and safety of a single-dose hyaluronic acid (Promovia hydro balance) in the treatment of non-traumatic degenerative meniscus tears
Read the 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.
- Conditions
- Meniscus Tears
- Being tested
- Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose
- Keywords
- meniscus tears, promovia hydro balance, hyaluronic acid, viscosupplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehaloseDevice
Promovia Hydro Balance 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-traumatic degenerative meniscus lesions | Experimental | Not described Receives: Device: Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline in the evaluation at 6 Months
Secondary outcomes (5)
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Baseline at time of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Meniscus TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innate srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ASST Gaetano Pini-CTO
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539194
- Sponsor's protocol ID
- PROHYBA
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Performance and Safety of a Single-dose Hyaluronic Acid (Promovia Hydro Balance) in the Treatment of Non-traumatic Degenerative Meniscus Tears
- ClinicalTrials.gov ID
- NCT07539194
- Acronym / sponsor ID
- PROHYBA
- Conditions
- Meniscus Tears
- Keywords
- meniscus tears, promovia hydro balance, hyaluronic acid, viscosupplementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Innate srlIndustry (pharma, biotech, devices)
- Collaborators
- ASST Gaetano Pini-CTO
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with non-traumatic degenerative meniscus lesions | Experimental | Device: Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- - 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.
Key exclusion criteria (11 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalosePromovia Hydro Balance 100 mg | Device | Patients with non-traumatic degenerative meniscus lesions |
Primary outcome
Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy
Time frame: 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
5 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Meniscus Tears
Recruiting
Effects of Pulsed Electromagnetic Field Therapy on Meniscal Healing, Symptom Relief, and Knee Function
Meniscal Tears
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes
Recruiting
Novel Bioactive Sleeve on Pain and PROMs
Meniscus Tear
Active, not recruitingPhase 3
Dronabinol After Arthroscopic Surgery
Knee Osteoarthritis, Knee Injuries
Not yet recruitingObservational study
Ocular Surface Changes and Meibomian Gland Dysfunction in Rheumatologic Patients
Meibomian Gland Dysfunction, Dry Eye Syndromes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose in people with Meniscus Tears, run by Innate srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giulia Avio (+393925481157, giulia.avio@innate.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evalution T6 with Koos (Knee injury and Osteoarthritis Outcome Score): efficacy (time frame: Change from Baseline in the evaluation at 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.