NCT07539194

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

April 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 13, 2026

Last Update Submit

April 13, 2026

Conditions

Meniscus Tears

Keywords

meniscus tearspromovia hydro balancehyaluronic acidviscosupplementation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Performance evaluation T3 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)

    Change from Baseline in the evaluation at 3 Months

  • Numerical Rating Scale (NRS) at T3 compared to baseline

    Change from Baseline in NRS at 3 month from T0

  • Numerical Rating Scale (NRS) at 6 months

    Change from Baseline in NRS at 6 months from T0

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 6 months

    Change from Baseline at time of 6 months.

Other Outcomes (4)

  • AE and SAE

    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

  • consumption of analgesic/fans

    consumption of analgesic/fans at 3 months from T0

  • +1 more other outcomes

Study Arms (1)

Patients with non-traumatic degenerative meniscus lesions

EXPERIMENTAL
Device: Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehalose

Interventions

Promovia Hydro Balance 100 mg, Hyaluronic acid sodium salt and trehaloseDEVICE

Promovia Hydro Balance 100 mg

Patients with non-traumatic degenerative meniscus lesions

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASST Centro Specialistico Ortopedico Traumatologico Gaetano Pini-CTO

Milan, MI, Italy

RECRUITING

Central Study Contacts

Giulia Avio

CONTACT

+393925481157giulia.avio@innate.it

Chiara Fossati, medical doctor

CONTACT

ichiara.fossati@asst-pini-cto.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2026

First Posted

April 20, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)