Trials / Completed
CompletedNCT06975631
Post-market Study on TrHCROSS® in Knee Osteoarthritis After a Single Injection
Post-market Study for the Evaluation of the Effectiveness and Safety of Treatment With TrHCROSS by i+Med in Knee Osteoarthritis After a Single Intra-articular Administration
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- i+Med S.Coop. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Double-blind study assessing the safety and efficacy of TrHCROSS® in knee osteoarthritis, compared to Hyalone®, using scales such as WOMAC, VAS, and KOOS. The population includes 60 symptomatic patients with mild to moderate KOA (Kellgren-Lawrence II or III) who have not responded adequately to non-pharmacological treatments or simple analgesics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TrHCROSS® | Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked. |
| DEVICE | Hyalone® | Single injection of 4.4 ml of viscoelastic sodium hyaluronate solution crosslinked |
Timeline
- Start date
- 2022-06-02
- Primary completion
- 2023-08-10
- Completion
- 2024-02-14
- First posted
- 2025-05-16
- Last updated
- 2025-05-21
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT06975631. Inclusion in this directory is not an endorsement.